Browse Device Recalls

34,608 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 34,608 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 34,608 FDA device recalls — Class II.

Clear
DateProductReasonClassFirm
Mar 9, 2026 LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 9, 2026 LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554 Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subs... Class II LSL Healthcare Inc.
Mar 7, 2026 Philips Spectral CT on Rails. Model Number: 728334. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... Class II PHILIPS MEDICAL SYSTEMS
Mar 6, 2026 The product is a handheld ultraviolet-C germicidal wand and contains two low-... In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at l... Class II Uvlizer c/o RAIS INTERNATIONAL LLC
Mar 6, 2026 The product is a handheld ultraviolet-C germicidal wand and contains a combin... In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at l... Class II Uvlizer c/o RAIS INTERNATIONAL LLC
Mar 6, 2026 CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical ... Software issue that renders the touch screen unresponsive. Class II Integra LifeSciences Corp. (NeuroSciences)
Mar 5, 2026 COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Nu... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAY... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Re... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: R... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small,... Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatibl... Class II Tornier, Inc
Mar 5, 2026 COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200,... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-19... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-1... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: ... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part N... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Par... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.... Products from the affected device lots were labeled with expiration dates that exceed the true sh... Class II Cook Incorporated
Mar 5, 2026 Vue Motion V12. Product Number: 1017979. Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 4, 2026 Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... Product labeling includes a fetal indication for use that is not cleared under its 510(k). Class II Koven Technology, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 03... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100C... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU ... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 0... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACC... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100C... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65C... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 03... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; A... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 03... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Marker... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038... The affected devices contain a manufacturing defect which may prevent the appropriately sized gui... Class II Angiodynamics, Inc.
Mar 3, 2026 Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO Due to increased in complaints their is the potential for endoscopic clipping device to malfunct... Class II Wilson-Cook Medical Inc.
Mar 3, 2026 ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Mar 3, 2026 Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; Philips has identified instances where X-ray imaging may not be initiated or may occur intermitte... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.