Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Dental Abutment labeled in part: “4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ… Reports relating to Biomet 3i’s BellaTek Zirconia Dental Abutment fractures were received. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall syngo Dynamics Picture Archiving and Communication System (PACS) Potential patient data mixup. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Georgia, Iowa, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic… The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereFlorida, Illinois, Missouri, New Jersey, New York, Oregon and Pennsylvania
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2” connector, 14.5” During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2” connector, 14.5” During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2” connector, 15” During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2” connector, 15” During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2” connector, 15” During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2” flare The Sarns Malleable Dual-stage Venous… During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2” flare The Sarns Malleable Dual-stage Venous… During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report15 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Illinois, Indiana, Louisiana, Michigan, Minnesota, Missouri, North Carolina, New York, Pennsylvania, Tennessee and Texas
- Medical device recall Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389 Philip’s is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report20 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Kansas, Maryland, Maine, Michigan, Mississippi, North Carolina, New Mexico, New York, Pennsylvania, Texas, Virginia, Washington and Wisconsin
- Medical device recall VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly… The product may fail to achieve seal of right lung due to the cuff inflating to one side Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin… Individual pieces of a batch of Biomet’s Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number. Class IIIFDA’s classMar 26, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 26, 2014ClassClass IIIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Hawaii, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Texas, Virginia and Washington
- Medical device recall MEDITECH Microbiology Potential for erroneous result reporting. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Buzzaround XL scooters’ Product Usage: mobility Buzzaround XL scooters’ front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated… The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley… The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter… The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall ‘TORAY’ Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters… The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters… The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used… Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Michigan, New York and Texas named
- Medical device recall Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique… Incorrect labeling on specific lots of the Intramedullary Bone Saw. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Michigan, New York and Texas named
- Medical device recall Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique… Incorrect labeling on specific lots of the Intramedullary Bone Saw. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Michigan, New York and Texas named
- Medical device recall GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3 GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Indiana, Massachusetts, North Carolina, New Jersey, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B Some of the discs may not be impregnated with the antibiotic. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and… Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Idaho, Indiana, Nevada, Oregon, South Dakota, Tennessee and Washington
- Medical device recall Gender Solutions” Natural-Knee¿ Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MOST Options” System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿/Apollo” Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Apollo” Knee System: APOLLO PATELLA SZ0 28MM R A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Apollo” Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Apollo” Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY… A complaint was received for a discolored All Poly Tibia. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.… A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis.… A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named
- Medical device recall Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical… Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Massachusetts, Maryland, Mississippi, Pennsylvania, Tennessee and Texas named
- Medical device recall Otto Bock Aerial and Aerial Active Wheelchair Cushions Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. Class IIFDA’s classMar 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2014ClassClass IIStatusTerminatedWhereNationwide
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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