Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 10, 2025 | Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal... | Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative... | Class II | Immuno-Mycologics, Inc |
| Feb 10, 2025 | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Under certain circumstances, it can occur that patient records from unrelated individuals are aut... | Class II | Brainlab AG |
| Feb 10, 2025 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12... | Customer-designed sterile surgical procedure packs contain latex components as specified; but, th... | Class II | Alcon Research LLC |
| Feb 7, 2025 | Bodor's I series laser cutting machine. | The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(... | Class II | Jinan Bodor Cnc Machine Co Ltd |
| Feb 7, 2025 | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. G... | Catheter manufactured at the incorrect length. | Class II | Cordis US Corp |
| Feb 7, 2025 | CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibril... | Damage to the sterile barrier pouch of catheter, which could potentially compromise its sterility. | Class II | CardioFocus, Inc. |
| Feb 6, 2025 | MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01... | 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 PACK, Model Nos LLLD19H | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, ... | Possibility for the obturator to break (separate). | Class II | Integra LifeSciences Corp. |
| Feb 6, 2025 | GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08 | 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 PACK, Model Nos LLCS44F LLCS44F-01 | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or ... | Class II | American Contract Systems Inc |
| Feb 6, 2025 | DIAGNOSTIC NEURO IR TRAY , Model No WENE21 | 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 |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... | Sync timeout may occur between the server and automated dispensing device, due to a server softwa... | Class II | CareFusion 303, 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, M... | Devices may have higher than expected amounts of bacterial endotoxin. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 6, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component P... | Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent sto... | Class II | Beckman Coulter, 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 | 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 | 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 | 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 | 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 | 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 | 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 5, 2025 | MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (... | Entering multiple keys that trigger input simultaneously may remove data from first field of scre... | Class II | Medical Information Technology, Inc. |
| Feb 5, 2025 | Access 2 Immunoassay Analyzer, Catalog Number 81600N | Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alig... | Class II | Beckman Coulter, Inc. |
| Feb 5, 2025 | IntelePACS (Image Fusion Module) - InteleViewer | A software application that receives digital images and data from various sources has a bug in sp... | Class II | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Feb 5, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137. | the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage error... | Class II | Beckman Coulter, Inc. |
| Feb 4, 2025 | IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UP... | Product is mislabeled with the incorrect fill volume. | Class II | Angiodynamics, Inc. |
| Feb 4, 2025 | CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit. | During an internal investigation, ACS was unable to confirm that the CODMAN component achieved th... | Class II | American Contract Systems Inc |
| Feb 3, 2025 | CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital S... | Due to issues associated with data migration of patient information and results to a Cloud servic... | Class II | St. Jude Medical |
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.