Browse Device Recalls
37 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 37 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 37 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Vitrectomy Cutter, Product/Part Number 70935, packaged ... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Procedure Pack with Photon Wide Field Illuminator, Prod... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics Inc |
| Aug 11, 2016 | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 700... | Vitrectomy cutters have been found not to be operating within the correct pressure pulse per spec... | Class II | Synergetics 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 |
| 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 |
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.