Browse Device Recalls

5,424 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,424 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 5,424 FDA device recalls.

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DateProductReasonClassFirm
Dec 16, 2022 HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... Class II Access Vascular, Inc
Dec 15, 2022 PICC KIT, 10/CS, ACCESS MEDICAL LABEL Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in t... Class II Stradis Healthcare
Dec 15, 2022 HIGH V+ Spinal Cement System REF T040321K Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration d... Class II TEKNIMED SAS
Dec 12, 2022 BD Pyxis MedBank System - Product Label/labeling pending Due to customer complaints related to the MedBank software which may indicate that a different me... Class II CareFusion 303, Inc.
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasa... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 8, 2022 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotrache... Potential for pilot balloon non-inflation or cuff non-deflation. Class II TELEFLEX LLC
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reo... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Nu... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOM... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST T... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder N... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRA... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJ... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... Stryker received one report of an injury to an untrained user that occurred while the untrained u... Class II Mobius Imaging, LLC
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYND... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PI... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYN... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Re... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Num... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY,... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 7, 2022 Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder... The recall is due to the perforated bag not allowing for outside of the kit wrapping to be steril... Class II MEDLINE INDUSTRIES, LP - Northfield
Dec 5, 2022 Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 mislabeled product Class III Young Dental Manufacturing I, LLC
Dec 2, 2022 Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-182... The stylet is longer than specified on the label Class II Remington Medical, Inc.
Nov 28, 2022 Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tes... Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emer... Class I Universal Meditech Inc.
Nov 23, 2022 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopi... The product is labeled with the incorrect expiration date. Class II Covidien, LLC
Nov 18, 2022 Medline CISION Sterile Blades. Labeled as follows with corresponding Item Nu... Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging. Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. MINOR/BREAST BIOPSY... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PORT/TRACH INSERTIO... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ENDOSCOPY-LF b. S... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. SPINAL b. SPINE CDS... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. PELVISCOPY PACK ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: IM NAIL Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY ... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR B... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b.... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: a. GYN-URO LAPSCP CD... Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Sterile Procedural Trays, labeled as the following: LS MS PACK Sterile blades within sterile kits have the potential for the blade to puncture the outer foil la... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 17, 2022 Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the ... Class II MEDLINE INDUSTRIES, LP - Northfield

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.