Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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Date	Product	Reason	Class	Firm
Sep 15, 2020	Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage...	Corrosion could cause performance failures in the product.	Class II	3M Company - Health Care Business
Sep 15, 2020	3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to b...	Corrosion could cause performance failures in the product.	Class II	3M Company - Health Care Business
Sep 15, 2020	Quick Release Gait Belt, 60	The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma...	Class II	Medline Industries Inc
Sep 14, 2020	Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the p...	Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to...	Class II	Becton Dickinson & Company
Sep 14, 2020	Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Mode...	The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator...	Class II	Philips North America, LLC
Sep 14, 2020	Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.	Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of wavefo...	Class II	Percussionaire Corporation
Sep 14, 2020	Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model ...	The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator...	Class II	Philips North America, LLC
Sep 14, 2020	Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the pe...	Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to...	Class II	Becton Dickinson & Company
Sep 14, 2020	Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us...	Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati...	Class II	Medline Industries Inc
Sep 14, 2020	MR Coils The MR Coil is intended to be used in conjunction with a Magnetic...	The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protect...	Class III	Invivo Corporation
Sep 14, 2020	BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref...	Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay ...	Class II	Becton Dickinson & Company
Sep 12, 2020	Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR18...	The device may detect an incorrect Heater Bag volume which may lead to a 'Supply Bag Line Blocked...	Class II	Fresenius Medical Care Holdings, Inc.
Sep 11, 2020	Synapse PACS Software Versions 5.1 and higher	There is a potential for the wrong patient information may be displayed in the viewer or PowerJac...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020	Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Produc...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Us...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: i...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a we...	FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D ...	Class II	Fujifilm Medical Systems U.S.A., Inc.
Sep 11, 2020	Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN ...	The Streamline MIS Navigation System taps are not compatible with the Streamline MIS tap sleeve.	Class II	RTI Surgical, Inc. (dba Pioneer Surgical Techno...
Sep 11, 2020	Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product U...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 11, 2020	VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a compon...	VGDF (VGA) Faceplate failure results in failure of video signal for SkyVision Linx 300, a seconda...	Class II	Skytron, Div. The KMW Group, Inc
Sep 11, 2020	Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Pr...	The magnet located inside the foot pedal may come off and may result in unattended start of unsto...	Class II	Bien-Air Surgery Sa
Sep 10, 2020	Instructions For Use document of the GPS Trackers.	Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some...	Class II	Blue Ortho
Sep 10, 2020	t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump ...	Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump bat...	Class II	Tandem Diabetes Care Inc
Sep 9, 2020	TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Nu...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System	Due to secondary deployment fiber being attached to secondary deployment handle, completion of de...	Class II	W L Gore & Associates, Inc.
Sep 9, 2020	HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product N...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Numb...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors Product Number...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor Product Num...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor Product Number: 7...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors Product Num...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product N...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE -Absorbable Suture anchor Product Numb...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Num...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor Product Numb...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor Product Num...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product N...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE -Absorbable Suture anchor Product Numb...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.
Sep 9, 2020	GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System	When the delivery catheter was attempted to be removed, there was an observed connection between ...	Class II	W L Gore & Associates, Inc.
Sep 9, 2020	HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor Product Nu...	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re...	Class II	Smith & Nephew, Inc.

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.