Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 5, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall STERRAD 100NX Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose… Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for… Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered… Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and… A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Indiana, Maryland, Michigan, Nebraska, New York, Texas and Washington named
- Medical device recall Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral… The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Iowa, Kentucky, North Carolina, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and… There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to… Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures. The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereFlorida, Idaho, Louisiana, New York and Tennessee
- Medical device recall Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies… Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Hawaii, Indiana and Montana named
- Medical device recall Shortened Plug Driver Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH CEMENTED Size 2-3 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH CEMENTED Size 4-7 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SIGMA¿ LCS¿ HIGH PERFORMANCE” MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T DePuy Orthopaedics, Inc. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Montana, North Carolina, Nevada, New York, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall 20mm addEASE(TM) Binary Connector with 17 Ga Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 13mm addEASE(TM) Binary Connector with 17 Ga Possible solution leakage at the interface of the addEASE(TM) Binary Connector (Product Codes BC2000 and BC1300) and the PAB(R) bag. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. Class IIFDA’s classDec 4, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need… 3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns. Class IIIFDA’s classDec 4, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 4, 2013ClassClass IIIStatusTerminatedWhereFlorida, Indiana, Nevada, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Zinger¿ Stainless Steel Workhorse Guidewire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall THUNDER¿ Extra Support Guidewire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ProVia¿ CROSSING GUIDEWIRE Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ATTAIN HYBRID¿ Guide Wire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall COUGAR¿ Steerable Guidewire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall THUNDER¿ Steerable Guidewire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ZINGER¿ Steerable Guidewire Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VITROS Chemistry Products ACET Slides, 90 slides/pack Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products AcP Slides, 90 slides/pack Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products ALB Slides, 90 slides/pack Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products ALC Slides, 90 slides/pack Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products ALKP Slides, 300 slides/pack Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products AMON Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products AMYL Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products AST Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products BuBc Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products BUN/UREA Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products Ca Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CHE Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CHOL Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall VITROS Chemistry Products CK Slides Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. Class IIFDA’s classNov 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedNov 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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