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.

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DateProductReasonClassFirm
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.