Browse Device Recalls
1,062 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,062 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 1,062 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 24, 2025 | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tournique... | Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... | Class II | Zimmer Surgical Inc |
| Dec 24, 2025 | Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tournique... | Device user interface (screen) may freeze or become unresponsive to touch when operating in certa... | Class II | Zimmer Surgical Inc |
| Dec 5, 2025 | Revogene C. difficile, in vitro diagnostic assay intended for use with the Re... | The affected lots show a decline in performance over time, which may lead to false-negative results. | Class II | Meridian Bioscience Inc |
| Nov 24, 2025 | Zimmer Dermatome AN, Model/Catalog Number: 88710100 | The devices may have a misaligned thickness control bar. | Class II | Zimmer Surgical Inc |
| Nov 24, 2025 | Zimmer Air Dermatome, Model/Catalog Number: 00880100100 | The devices may have a misaligned thickness control bar. | Class II | Zimmer Surgical Inc |
| Nov 19, 2025 | AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De... | Wire connected to the electrical box may shift out of its intended position, which may result in ... | Class II | Steris Corporation |
| Nov 19, 2025 | AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des... | Wire connected to the electrical box may shift out of its intended position, which may result in ... | Class II | Steris Corporation |
| Oct 7, 2025 | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Ac... | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... | Class II | Meridian Bioscience Inc |
| Oct 7, 2025 | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Ac... | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... | Class II | Meridian Bioscience Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Sep 16, 2025 | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, im... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| 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 |
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.