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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal f... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAI... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
Jul 11, 2025 ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED,... Unidentified substance of unknown impact was identified on devices during a retrospective evaluat... Class II Onkos Surgical, Inc.
May 20, 2025 My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It... Required inspections were not performed on finished product prior to release and distribution. Class II Onkos Surgical, Inc.
Sep 22, 2024 ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL... Potential challenge with intraoperative assembly of the external taper of a single midsection wit... Class II Onkos Surgical, Inc.
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Dec 22, 2023 ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03... Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that ... Class II Onkos Surgical, Inc.
Sep 1, 2023 Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-0... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Male-Female Midsection with the following sizes and model numbers. a. Male... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Segmental Stem, Cemented, Bowed, 152MM, 1 EACH. Model Numbers: CB-11152-03M, ... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-111... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-0... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
Sep 1, 2023 a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100... Potential for breach of Tyvek seals. Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos Surgical, Inc.
May 23, 2017 ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGT... The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm Class II Onkos 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.