Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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 6, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall CMS-4975 HSG Tray containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-5284 Custom Myelogram Tray containing 2 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall The product affected by this notice is This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Michigan, New York, Oklahoma and Oregon
- Medical device recall HALO Flex Energy Generators Potential failure of HALO Energy Generator to enter “stand by” mode when initially powered on; and therefore can not be used for patient care. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spacelabs Ultraview DM3 Monitor Unit fails to power up, resulting in an equipment alarm Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Washington named
- Medical device recall The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes… Integra’ s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Ultraview SL 91493 Integrated Module Housing There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips DigitalDiagnost Systems with M Cabinet Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereOhio and Washington
- Medical device recall Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MX 16-slice CT Scanner System, models 728131 and 728132 On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches the oil accumulator within the gantry may fail, resulting in… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania and Virginia named
- Medical device recall Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random… Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereIllinois
- Medical device recall 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL One lot of 0.9% Sodium Chloride Flush syringe, 3 mL in 12 mL may be mislabeled as 0.9% Sodium Chloride Flush syringe, 10 mL in 12 mL. Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereIllinois
- Medical device recall Empty Evacuated Container 250 mL and 1000 mL Embedded iron oxide glass defect which may have the potential to break off into the solution. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH… US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Iowa, Illinois, Massachusetts, Maine, Minnesota, Missouri, North Carolina, New Hampshire, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131 Incorrect version of the CD was included with BD FACS 7 Color Setup Beads. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet,… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Georgia, Indiana, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington and Wisconsin named
- Medical device recall Guardian II Hemostasis Valve Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal from Guardian II (Model 8210) and Guardian II NC (Model FH102)… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Minnesota, Missouri, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical… Shipped with incorrect software Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Louisiana, Massachusetts, Maine, North Carolina, North Dakota, Nebraska and Ohio named
- Medical device recall A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table Customers may be storing objects on the base and/or around the column of the surgical table. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS… When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System… Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or… Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Massachusetts, Maryland, North Carolina, Ohio, Pennsylvania, Texas and Washington named
- Medical device recall Precise Digital Accelerator Delivery of radiation to defined target volumes There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Octopus 101 Perimeter The firm recalled the device after learning of a possible deviation in the stimulus luminance of the Perimeter OCTOPUS 101. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Washington, Wisconsin and West Virginia named
- Medical device recall Bard Ventralight ST Mesh. - Ellipse 8” x 10” Mislabeled: The 8” x 10” package contains 7” x 9” VENTRALIGHT ST Mesh product and the 7” x 9” package contains 8” x 10” VENTRALIGHT ST Mesh product Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard Ventralight ST Mesh. - Ellipse 7” x 9” Mislabeled: The 8” x 10” package contains 7” x 9” VENTRALIGHT ST Mesh product and the 7” x 9” package contains 8” x 10” VENTRALIGHT ST Mesh Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed Orthopaedics, Inc. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts, North Carolina, Ohio and Texas named
- Medical device recall Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous… The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous… The placement guidewire diameter is too large and does not pass-through the introducer needle during the placement procedure of the PEG Feeding Tube. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Verify¿ Bowie-Dick Test Card STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specifications. Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 36 states named PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter Asahi became aware of a negative trend for rate of the adverse events that may be associated with a manufacturing change to certain lot numbers of the… Class IIFDA’s classSep 26, 2012in FDA’s Enforcement ReportTennesseethe one state its words name PublishedSep 26, 2012ClassClass IIStatusTerminatedWhereTennessee
- Medical device recall ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File The impacted product was not intended for commercial distribution to end users. Class IIIFDA’s classSep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IIIStatusTerminatedWhereNationwide, and California, Colorado, Louisiana, New Mexico, Oklahoma, Texas and Washington 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.”
Your shortlist0 of 4
Add one more to compare.