Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANI... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOM... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 6, 2024 ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... Due to finished goods incorrectly packaged and labeled. Class II ICU Medical, Inc.
Nov 6, 2024 Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY,... Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to cont... Class II MEDLINE INDUSTRIES, LP - Northfield
Nov 5, 2024 GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... Class II GE Healthcare (China) Co., Ltd.
Nov 1, 2024 Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA ins... The DNA fragments for this specific lot number are too large, resulting in potential background a... Class II Kreatech Biotechnology Bv
Oct 28, 2024 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a de... Due to incorrect labels applied to devices during servicing. Labels contain the incorrect produc... Class III Remote Diagnostic Technologies Ltd.
Oct 28, 2024 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 28, 2024 AMS Artificial Urinary Sphincter Control Pump Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 25, 2024 ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Me... Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expir... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINE KIT, SKU DYKM1845; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004... Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 UA KIT, SKU DYKM1690A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Clean Catch Kit, SKU DYKM1833A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 23, 2024 Lab Kit, SKU DYLAB1018; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 21, 2024 Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... Due to improper labeling of products. An intended use on the label has not been reviewed and appr... Class II Karl Storz Endoscopy
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 Smaxel Fractional CO2 Laser, a Class IV medical laser system. The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions... Class II IDS LTD
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY,... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE B... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix... Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical mat... Class II CORNEAT VISION, LTD.
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJR... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE,... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 16, 2024 MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF P... The connectors may not allow catheters to be inserted as intended if the connector is not in the ... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 15, 2024 a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340... Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes... Class III Alcon Research LLC
Oct 14, 2024 Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Devices from the affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 14, 2024 Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: L... Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... Class II Defibtech, LLC
Oct 14, 2024 Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline... Within the Irish Market, a Field Safety Notice is being issued due to a select number of authoriz... Class II Defibtech, LLC
Oct 14, 2024 Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: ... Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... Class II Defibtech, LLC
Oct 14, 2024 Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifel... Within the Irish Market, that a Field Safety Notice is being issued due to a select number of aut... Class II Defibtech, LLC
Oct 9, 2024 MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS76005... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ01... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYN... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY ... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ524... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VAS... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... 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.