Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 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 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 27, 2015 | Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Po... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Feb 10, 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medic... | The firm has determined the product may fail to dispense the sample to the agar plate resulting i... | Class II | Biomerieux Inc |
| Dec 9, 2013 | 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, ste... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile /... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, st... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Pa... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, le... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, s... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetic... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile ... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, steri... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, ster... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile /... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Dec 9, 2013 | 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 5... | Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic... | Class II | Synergetics Inc |
| Oct 30, 2013 | Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #... | The lift might fail with the labeled 500-lb. load rating. | Class II | Ergosafe Products LLC DBA Prism Medical Service... |
| Oct 30, 2013 | Medcare Products Max-500 Stand, Total Support, patient stand, model #400006. ... | The lift might fail with the labeled 500-lb. load rating. | Class II | Ergosafe Products LLC DBA Prism Medical Service... |
| Sep 10, 2013 | Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, pack... | Expired active ingredient was used in the manufacture of the product. | Class II | Wexford Labs Inc |
| Jul 30, 2013 | Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog n... | One lot of 25 gauge Soft-Tip Disposable Cannulas are co-mingled with 23 gauge cannulas; the produ... | Class II | Synergetics Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | 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.