Browse Device Recalls
1,114 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,114 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 1,114 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 23, 2026 | HexaVue Focus Integration System, a single, all-in-one system that handles op... | A software issue may result in unintended mismatch of patient information on manually printed ima... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Sep 21, 2026 | RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115 | If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased ... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3069 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Numb... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number... | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 31, 2026 | VERIFY Biological Steam Test Pack Model/Catalog Number: S3065 | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf... | Class II | Steris Corporation |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 21, 2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and ... | A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Me... | Class II | Midmark Corporation |
| Aug 14, 2026 | Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog N... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 14, 2026 | Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Num... | Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves ma... | Class II | American Nitrile Operations Llc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| Aug 10, 2026 | Medical convenience kits containing BD CliniClean Pericare Wipes within BD Ur... | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, ... | Class II | American Contract Systems Inc |
| 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 | Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack (10 pk), Item Nu... | Affected kits were assembled with pediatric nasal cannula instead of the intended adult nasal can... | Class II | Sarnova HC, Llc |
| 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 28, 2026 | Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power... | Firmware issue may result in intermittent loss or degradation of powered functionality when paire... | Class II | Ferno-Washington Inc |
| 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. |
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.