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
Jul 20, 2026 Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Soft... A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... Class II Midmark Corporation
Jul 20, 2026 Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software ... A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an i... Class II Midmark Corporation
Jul 13, 2026 Innercool Coolblue Console, Model STx; Thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down. Class II Gentherm Medical, LLC
Jul 13, 2026 Blanketrol III, Model 233; Thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down. Class II Gentherm Medical, LLC
Jul 13, 2026 Blanketrol II Model 222S; Thermal regulating system. Overheating of the 115V CPU board may cause the device to shut down. Class II Gentherm Medical, LLC
Jul 1, 2026 5-PLASMA Bivalirudin Control, Model Number 5D-44905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jul 1, 2026 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jul 1, 2026 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been... Class II Aniara Diagnostica LLC
Jun 29, 2026 American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: T... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TN... The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 29, 2026 American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: L... The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubb... Class II American Contract Systems Inc
Jun 19, 2026 Power F2 Powered Fastening System, Product No. 0567091 Powered fastening sy... Product may experience accelerated roller wear and potential deformation due to interference betw... Class II Ferno-Washington Inc
Jun 12, 2026 ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative m... The Test cup lot F level 1 low-quality control results values for the device were lower than expe... Class II Tosoh Bioscience Inc
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
Jun 9, 2026 Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet... Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderat... Class II Zimmer Surgical Inc
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 15, 2026 ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
Apr 24, 2026 HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual pack... Class II Devicor Medical Products Inc
Apr 1, 2026 ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated ... Class II Aniara Diagnostica LLC
Mar 19, 2026 Convenience kits containing Medline Namic Angiographic Control Syringes with ... Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwin... Class I American Contract Systems Inc
Mar 5, 2026 Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... Class II Daavlin Distributing Company
Mar 5, 2026 Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... Class II Daavlin Distributing Company
Mar 5, 2026 Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disor... Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GA... Class II Daavlin Distributing Company
Feb 4, 2026 React Health PHOENIX 5L Oxygen Concentrator Devices which did not meet internal quality specifications were inadvertently distributed. Class II 3B Medical, Inc.
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 10, 2025 Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin ... Some of the Calibration/Output Certificates had the outputs reversed. Class II Daavlin Distributing Company
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

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.