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Browse Device Recalls

17 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 17 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 17 FDA device recalls.

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DateProductReasonClassFirm
May 23, 2023 SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 c... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 ... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x2... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm,... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, Inc.
May 23, 2023 PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 1... Possible out of specification endotoxin test results due to issues with in-process and finished g... Class II TEI Biosciences, 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.