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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.