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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Jul 3, 2018 Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Jul 3, 2018 Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... Vials labeled for the prescriptions contained incorrect lenses Class III Alden Optical
Nov 3, 2017 ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 P... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Pr... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Pro... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: ... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 P... Contact lenses lack sterility assurance. Class II Alden Optical
Nov 3, 2017 NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Us... Contact lenses lack sterility assurance. Class II Alden Optical

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.