Browse Device Recalls
917 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 917 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 917 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packa... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packa... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packa... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Wid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Aug 8, 2018 | Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wid... | The back cap separates from the body of the vitrectomy cutter. | Class II | Bausch & Lomb Inc |
| Mar 20, 2018 | First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/ca... | Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) ... | Class II | Certified Safety Mfg Inc |
| Mar 7, 2018 | Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resteri... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Vascular Solutions Venture Rx Catheter, 6F, resterilized. | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic B... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40C... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Bili... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 34F (11.... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Mar 7, 2018 | Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula, 29/37F (9.6/12.... | The expiration date on the device labeling exceeds its actual validated shelf life because the st... | Class II | SPS Sterilization, Inc |
| Jan 23, 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... | Missing desiccant. | Class II | Biomerieux Inc |
| Dec 28, 2017 | HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: ... | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... | Class II | Southwest Technologies Inc |
| Dec 28, 2017 | HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brand... | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... | Class II | Southwest Technologies Inc |
| Dec 28, 2017 | HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (... | Hypothermia mitts, hypothermia slippers, and hypothermia caps on the market are misbranded for us... | Class II | Southwest Technologies Inc |
| Nov 3, 2017 | Handicare P600 Series Patient Lift Product Usage: A device used to lift and... | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Handicare Usa Inc |
| Nov 3, 2017 | Handicare C Series Patient Lift Product Usage: A device used to lift and ... | Premature strap wear and breakage at maximum weight conditions (625 lbs.). | Class II | Handicare Usa Inc |
| Oct 11, 2017 | VITEK2 GP-ID, REF 21342 IVD | Customers have reported, and an internal investigation has confirmed, occurrences of atypical neg... | Class II | Biomerieux Inc |
| Sep 25, 2017 | Regard Custom Surgical Pack Packs contain surgical instruments and accesso... | Resource Optimization & Innovation, LLC (ROi) received a recall notice from BD for an incorrect l... | Class II | Resource Optimization & Innovation Llc |
| Sep 8, 2017 | PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered | During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap ... | Class II | Handicare Usa Inc |
| Sep 1, 2017 | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. | Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to... | Class II | Elekta Inc |
| Aug 25, 2017 | VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R)... | Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus... | Class II | Biomerieux Inc |
| Jul 12, 2017 | VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent card... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jul 12, 2017 | VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and... | Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizin... | Class II | Biomerieux Inc |
| Jun 26, 2017 | Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva ... | Burn Sheet has possibility of being shredded. | Class II | Certified Safety Mfg Inc |
| May 16, 2017 | VITEK 2 Gram Negative test kits containing colistin (cs01n) | The investigation demonstrated a high rate of very major errors (resistant isolates calling susce... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N293), REF 415369, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards pe... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 ca... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards p... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
| Apr 20, 2017 | VITEK¿ 2 Gram Positive Susceptibility card (AST-P606), REF 22330, 20 cards pe... | The integrity of the product container may be compromised thereby exposing product to moisture wh... | Class II | Biomerieux Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.