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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jun 12, 2025 ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL Due to defects (bubbles/voids) identified during standard finished goods testing Class II Johnson & Johnson Vision Care, Inc.
May 6, 2021 ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base... Potential that a limited number of individual contact lens packages have an incomplete packaging ... Class II Johnson & Johnson Vision Care, Inc.
Mar 11, 2019 ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive ... One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited num... Class II Johnson & Johnson Vision Care, Inc.
Jul 23, 2018 Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve... Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, ... Class II Johnson & Johnson Vision Care, Inc.
Dec 18, 2017 ACUVUE OASYS for ASTIGMATISM Brand Contact Lenses. Lot no. B00NKM0G. Base Cur... Package integrity failure observed during routine shift package integrity testing at an external ... Class II Johnson & Johnson Vision Care, Inc.
Oct 19, 2017 1-DAY ACUVUE Moist for ASTIGMATISM Brand Contact Lenses Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 19, 2017 ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Oct 19, 2017 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR Some contact lenses were associated with complaints of a foreign matter caught between the bliste... Class II Johnson & Johnson Vision Care, Inc.
Dec 21, 2012 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. T... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, Inc.
Dec 21, 2012 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, 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.