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.

Date	Product	Reason	Class	Firm
Dec 2, 2020	EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	CoaguChek XS Prof (Professional) Meters- IVD professional healthcare provider...	Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ...	Class II	Roche Diagnostics Operations, Inc.
Dec 2, 2020	7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Produc...	Due to the incorrect filter assembly.	Class II	ICU Medical, Inc.
Dec 2, 2020	CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting t...	Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing ...	Class II	Roche Diagnostics Operations, Inc.
Dec 2, 2020	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage:...	Due to the incorrect filter assembly.	Class II	ICU Medical, Inc.
Dec 2, 2020	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	EMBLEM MRI S-ICD Model A219	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 2, 2020	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens...	Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020	Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens....	Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p...	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following stea...	Class II	Steris Corporation
Dec 2, 2020	EMBLEM S-ICD Model A209	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 2, 2020	60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron F...	Due to the incorrect filter assembly.	Class II	ICU Medical, Inc.
Dec 2, 2020	Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens...	Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient res...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 2, 2020	MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of ant...	Due to a customer report and internal investigation, it was confirmed that a portion of the affec...	Class II	Beckman Coulter Inc.
Dec 1, 2020	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: int...	Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure	Class II	Biomet, Inc.
Dec 1, 2020	AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Nov 30, 2020	Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno	When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30...	Class II	Siemens Medical Solutions USA, Inc
Nov 25, 2020	RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, Inc.
Nov 25, 2020	3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5...	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach...	Class II	Biomet, 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-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 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-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.

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.