Browse Device Recalls

1,092 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,092 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 1,092 FDA device recalls in OH.

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DateProductReasonClassFirm
Sep 11, 2025 iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22... Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impac... Class II Theken Companies LLC
Sep 11, 2025 ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection... The devices were shipped unsterilized. Class II Ethicon Endo-Surgery Inc
Sep 11, 2025 FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE ... The fastening post hardware could loosen allowing the fastening post to detach from the cot Class II Ferno-Washington Inc
Aug 12, 2025 NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NR... The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... Class II Applied Medical Technology Inc
Aug 12, 2025 NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NR... The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... Class II Applied Medical Technology Inc
Aug 12, 2025 NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NR... The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... Class II Applied Medical Technology Inc
Aug 12, 2025 NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NR... The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... Class II Applied Medical Technology Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
Jun 23, 2025 Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L... The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly... Class II Steris Corporation
May 23, 2025 Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6... This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing ... Class II Steris Corporation
Apr 22, 2025 Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 ro... Firm has received an increase in reports regarding inadvertent instrument lockout during surgical... Class I Ethicon Endo-Surgery Inc
Apr 11, 2025 Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to na... Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may del... Class I Centerline Biomedical Inc
Feb 24, 2025 Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... Class II Checkpoint Surgical Inc
Feb 24, 2025 Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... Class II Checkpoint Surgical Inc
Feb 19, 2025 MIM software; System, Image Processing, Radiological In situations where two images with differing Fields of View (FOV) complete an image fusion, an i... Class II MIM Software Inc
Feb 6, 2025 TOTAL HIP PACK , Model No SMTH06O SMTH06P ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 EAR PACK , Model No SFEA12A ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 NEURO IR TRAY , Model No WENI56J ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 CV BASIC PUMP PACK , Model No WECV23D ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 THORACIC PACK , Model No UTTC82Y UTTC82AA-01 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 AV FISTULA , Model No UTAV77T ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 BORN ON ARRIVAL KIT , Model No LLBN11B ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 CYSTO PACK , Model N. HKCY31A ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 CYSTO , Model No SACY80R ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LAPAROSCOPY PACK , Model No SFLA02A SFLA02B ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems Inc
Feb 6, 2025 DELIVERY PACK , Model No SGDV22D-01 SGDV22E ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... Class II American Contract Systems 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.