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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
Feb 26, 2013 Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm. Milex :Part N... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Mod... Incorrect size was printed on the outer product packaging. Class II Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Proc... LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidoc... Class II Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Feb 26, 2013 Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... Pessary mislabeled outer package may not reflect the size of the product contained in the package Class III Cooper Surgical, Inc.
Oct 31, 2012 Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: U... Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu... Class II Cooper Surgical, Inc.
Oct 31, 2012 Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 ... Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu... Class II Cooper Surgical, 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.