Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

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DateProductReasonClassFirm
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
May 1, 2021 Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... Class II Philips North America Llc
Apr 30, 2021 NICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination Pack. ... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Apr 30, 2021 WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt... Nonconformities were discovered to the engineering specifications for implant plates and screws. Class II Wishbone Medical, Inc.
Apr 30, 2021 Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Tot... The sterilization contractor informed the company of a quality issue possibly affecting the steri... Class II RanD S.r.l.
Apr 30, 2021 ACE Control Set - IVD Control set for the quantitative determination of Angio... Claim for stability after reconstitution from lyophilized to liquid form does not meet the requir... Class III Sentinel CH SpA
Apr 30, 2021 Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned... Class II Fujifilm Medical Systems U.S.A., Inc.
Apr 30, 2021 Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 The sterilization contractor informed the company of a quality issue possibly affecting the steri... Class II RanD S.r.l.
Apr 30, 2021 CooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131. Dispo... The affected Wallach LOOP Electrodes were incorrectly packaged with a Round Electrode inside a pa... Class II CooperSurgical, Inc.
Apr 30, 2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... The devices may not meet the minimum required sterility assurance level. Class II Medline Industries Inc
Apr 30, 2021 Myriad-LX Light Source-for delivery of light to the surgical field to enhance... (1) Updated IFU for the LX Illumination Packs: Warning - Avoid contact between the distal openi... Class II Nico Corp.
Apr 29, 2021 Probe Cover - 6" x 3" x 96"-Ultrasonic Transducer Cover Item ID: SH22 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Co... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, St... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System,... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Tr... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Ster... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover ... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Ste... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Probe Cover, PU and Elastic Blue Bands - 6" x 48", with hole Item ID: SH17 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indica... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Tra... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion Syst... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29 No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Transducer Cover 18x147cm, Kit, VIP Film w/ Bands & EMM Gel- Ultrasonic Trans... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated f... The company was notified by their supplier of sterilization services for airway products in Italy... Class II Covidien, LP
Apr 29, 2021 Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, S... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfu... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover I... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion Sys... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Cust... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, ... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cove... No 510k for the product to be used in a natural or surgical opening to the body Class II Exact Medical Manufacturing, Inc.
Apr 29, 2021 Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System... Specific lots may have been manufactured with insufficient or incomplete welds. Class II Medtronic Perfusion Systems
Apr 29, 2021 Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion Sy... Specific lots may have been manufactured with insufficient or incomplete welds. 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.