Browse Device Recalls
2,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,276 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 2,276 FDA device recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 29, 2022 | NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c)... | The firm received reports of events related to airway obstruction while using NIM Standard Reinfo... | Class I | Medtronic Xomed, Inc. |
| Apr 29, 2022 | INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovin... | Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm,... | Class II | Maquet Cardiovascular, LLC |
| Apr 29, 2022 | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to s... | Due to products being shipped/distributed to customers after the products expiration date had past. | Class II | Nihon Kohden America Inc |
| Apr 28, 2022 | Centricity PACS RA1000 | Potential for Distance and Area measurements to display inaccurate measurement values when perfor... | Class II | GE Healthcare, LLC |
| Apr 28, 2022 | Centricity Cardiology CA1000 | Potential for Distance and Area measurements to display inaccurate measurement values when perfor... | Class II | GE Healthcare, LLC |
| Apr 28, 2022 | Centricity Enterprise Web | Potential for Distance and Area measurements to display inaccurate measurement values when perfor... | Class II | GE Healthcare, LLC |
| Apr 28, 2022 | Centricity Universal Viewer Zero Footprint Client | Potential for Distance and Area measurements to display inaccurate measurement values when perfor... | Class II | GE Healthcare, LLC |
| Apr 28, 2022 | Centricity Radiology RA600 | Potential for Distance and Area measurements to display inaccurate measurement values when perfor... | Class II | GE Healthcare, LLC |
| Apr 28, 2022 | Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) | Isopure received a report of a hazardous incident involving a device which had experienced an ele... | Class II | Isopure Corp |
| Apr 28, 2022 | FIRMap" Catheter, 60mm Basket | Incorrect product labeling. | Class II | Abbott |
| Apr 27, 2022 | X80 RADiant Photoelectric Therapy System | There is a potential compatibility issue with the systems and replacement treatment applicators. | Class II | Xstrahl Limited |
| Apr 27, 2022 | AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX; Axium Detachable Coil Syst... | Due to incorrect size and configuration labeling of the detachable coil system. | Class II | Micro Therapeutics, Inc. |
| Apr 26, 2022 | 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... | Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... | Class II | Daavlin Distributing Company |
| Apr 26, 2022 | 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control Syst... | Software issue, resuming an interrupted treatment will result in swap of utilized calibration tre... | Class II | Daavlin Distributing Company |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 26, 2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Due to a shift in the citrated blood reference range for a normal population, the ranges stated i... | Class II | Haemonetics Corporation |
| Apr 26, 2022 | In-Line ventilator adaptor | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara s... | Class I | Baxter Healthcare Corporation |
| Apr 26, 2022 | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... | Class II | Beaver Visitec International, Inc. |
| Apr 25, 2022 | CardioTek EP-TRACER Software V2.x. | Device did not pass electrical safety testing for adequate insulation. | Class II | CardioTek BV |
| Apr 25, 2022 | Field replacement back up batteries distributed on or after April 1, 2019 for... | Backup batteries can fail earlier than their estimated life. | Class II | GE Healthcare, LLC |
| Apr 25, 2022 | Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufac... | Backup batteries can fail earlier than their estimated life. | Class II | GE Healthcare, LLC |
| Apr 22, 2022 | Reliance Synergy Washer/Disinfector | The firm identified that when the electrical contactor component in the drying chamber of the Was... | Class II | Steris Corporation |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... | Class II | Fresenius Kabi USA, LLC |
| Apr 22, 2022 | INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 13... | Right nails were anodized, marked, and labelled as left nails and vice versa | Class II | Smith & Nephew Orthopaedics GmbH |
| Apr 22, 2022 | Surgical Suture Kit | There is uncertainty about the integrity of the methods used to ensure the sterile barrier integr... | Class II | Stradis Healthcare |
| Apr 22, 2022 | Ivenix Infusion System (IIS) | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | Class II | Ivenix, Inc. |
| Apr 22, 2022 | REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO, | There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 F... | Class II | Bard Peripheral Vascular Inc |
| Apr 22, 2022 | Colonovideoscope Model CF-H180AL | A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the ... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2022 | EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper ... | Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used ... | Class II | Olympus Corporation of the Americas |
| Apr 22, 2022 | SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contai... | Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, sk... | Class II | ConvaTec, Inc |
| Apr 21, 2022 | Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuat... | Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the ... | Class II | Atrium Medical Corporation |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | Effluent Sample Bag | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | 5 Prong Manifold Set (with Luer Connectors) | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS | The warning label was printed with the incorrect weight capacity. The correct weight limit is 400... | Class II | Oakworks Inc |
| Apr 21, 2022 | PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19 | Product label was printed without the UDI number and warning label was printed with the incorrect... | Class II | Oakworks Inc |
| Apr 21, 2022 | MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | Locking Cap for PD Catheter Adapter | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS | Sporadic reports were received of discoloration on the foam sponge on certain lots of the product... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 21, 2022 | APD Drain Manifold | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1... | Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may... | Class II | Dain Technology, Inc. (Subsidiary of Soundable ... |
| Apr 21, 2022 | 15 Liters Drain Bag | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2022 | 3,65 m Extension Set with Luer-lock Connector | Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distribut... | Class II | Baxter Healthcare Corporation |
| Apr 20, 2022 | Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | The C304-HIS device features a guide wire to access the vein, a valve to redu... | The firm's internal processes identified that certain lots may have an improperly sealed barrier ... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6 | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R | Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopt... | Class II | Olympus Corporation of the Americas |
| Apr 20, 2022 | Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is p... | Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s. | Class II | Medtronic Perfusion Systems |
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.