Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607 | Baxter is aware of several recalls by other manufacturers related to the potential risk of expos... | Class I | Baxter Healthcare Corporation |
| 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 | Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| 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 16, 2024 | Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| Oct 15, 2024 | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor t... | Battery movement led to damage of one of the battery cells causing it to short to the battery ret... | Class II | OrganOx Ltd |
| 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 15, 2024 | Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile. | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile;... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 862140... | The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use o... | Class I | Draeger Medical, Inc. |
| Oct 15, 2024 | Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I... | The Bipolar assembly contains an oversized Retainer Ring. | Class II | Smith & Nephew, Inc. |
| 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 11, 2024 | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagn... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively meas... | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, show... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Oct 11, 2024 | 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 2... | Due to holes detected in the inner barrier system that may compromise the sterility of the affect... | Class II | Karl Storz Endoscopy |
| Oct 11, 2024 | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiog... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Dia... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 10, 2024 | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software... | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calc... | Class II | Philips Medical Systems Technologies Ltd. |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRB... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | BioZorb Marker. Radiographic soft tissue marker. | Firm received reports of adverse events/complications that include serious injuries, such as pain... | Class I | Hologic, Inc |
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 9, 2024 | SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-u... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
| 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 | Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL | There have been cases of failure of the main board due to condensation water drained from the Pel... | Class II | Shimadzu Corp. Analytical & Measuring Instrumen... |
| Oct 9, 2024 | Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-us... | A limited number of IV bags have been found to leak during filling. | Class II | The Metrix Company |
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.