Browse Device Recalls

3,435 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,435 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 3,435 FDA device recalls — Class I.

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Date	Product	Reason	Class	Firm
Jan 22, 2021	ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular U...	Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section...	Class I	Acist Medical Systems
Dec 23, 2020	Fresh Whole Blood Transfusion Set (P/N 80-801 NSN 6515016574750) . Blood con...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood conveni...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood co...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenie...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 23, 2020	Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection ...	There is the potential of a bent or disconnected needle in one of the components of the convenien...	Class I	Combat Medical Systems, LLC
Dec 18, 2020	Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift wi...	Multirall Q-link strap lock has not been fully engaged in the S65 rail carriage hook by user, lea...	Class I	Hill-Rom, Inc.
Dec 15, 2020	Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperf...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Devic...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 15, 2020	Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing RE...	The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjun...	Class I	Penumbra Inc.
Dec 2, 2020	EMBLEM S-ICD Model A209	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 2, 2020	EMBLEM MRI S-ICD Model A219	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-R...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 24, 2020	Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G5...	There is an increased likelihood of the introducer sheath separating at the proximal bond site. ...	Class I	Cook Inc.
Nov 19, 2020	Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ...	Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini...	Class I	Heartware, Inc.
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 17, 2020	Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on ...	Failure to execute the visual inspection correctly prior to locking the valve during the deployme...	Class I	Boston Scientific Corporation
Nov 13, 2020	EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable car...	There is potential for fractures which results in the inability to delivery therapy.	Class I	Boston Scientific Corporation
Oct 22, 2020	Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved...	Affected product was dropped during manufacturing, which may result in a bent wire guide and/or t...	Class I	Cook Inc.
Sep 22, 2020	ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038...	When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated se...	Class I	Flexicare Medical Ltd.
Sep 21, 2020	Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM...	Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever ...	Class I	Stryker Neurovascular
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 31, 2020	Langston Dual Lumen Catheter.	The inner lumen of the Langston catheter may separate from the hub during pressure injection.	Class I	Vascular Solutions, Inc.
Aug 25, 2020	Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Singl...	Subsequent failure of catheters in the field and failed quality testing	Class I	Medtronic Vascular

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.