Browse Device Recalls

111 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 111 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 111 FDA device recalls.

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Date	Product	Reason	Class	Firm
Nov 19, 2025	AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product De...	Wire connected to the electrical box may shift out of its intended position, which may result in ...	Class II	Steris Corporation
Nov 19, 2025	AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Des...	Wire connected to the electrical box may shift out of its intended position, which may result in ...	Class II	Steris Corporation
Jun 23, 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical L...	The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly...	Class II	Steris Corporation
Jun 23, 2025	Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical L...	The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly...	Class II	Steris Corporation
May 23, 2025	Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6...	This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing ...	Class II	Steris Corporation
Jun 13, 2024	Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups ...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
Jun 13, 2024	Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups prov...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
Jun 13, 2024	Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
Jun 13, 2024	Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups prov...	IFU for hookup were incorrectly reflected within hookup IFUs and online reference system, Hookup ...	Class II	Steris Corporation
Jan 9, 2024	Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"	Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical...	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Dec 12, 2023	Dual Articulating Headrest, Velcro P/N P141210813, REF BF753	Dual-articulating head rest may not stay in place or may fail to lock into position during a pati...	Class II	Steris Corporation
Dec 12, 2023	Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754	Dual-articulating head rest may not stay in place or may fail to lock into position during a pati...	Class II	Steris Corporation
Nov 16, 2023	V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoc...	Bandage Scissors handle cover component contains an incorrect color masterbatch resin carrier. Th...	Class II	Steris Corporation
Nov 13, 2023	Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pa...	Identification label on affected hookups could become illegible over time due to the label's ink ...	Class II	Steris Corporation
Apr 10, 2023	Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062	In the remote occurrence in which the electrical contactor component present in the drying chambe...	Class II	Steris Corporation
Mar 17, 2023	Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 ...	Light handle covers may separate from the light handle (detach and fall off) during use, this cou...	Class II	Steris Corporation
Mar 17, 2023	Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)-...	Light handle covers may separate from the light handle (detach and fall off) during use, this cou...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Nu...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Inten...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item N...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Dec 12, 2022	VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Inte...	Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus s...	Class II	Steris Corporation
Oct 17, 2022	GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to ...	Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller pri...	Class II	Steris Corporation
Sep 2, 2022	Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360	The scalpel holder may separate from the handle for certain lots. If the tip falls off during use...	Class II	Steris Corporation
Aug 10, 2022	Verify SixCess Challenge Pack. Used to confirm that critical parameters of s...	Product contains incorrect chemical indicators in packaging.	Class III	Steris Corporation Hopkins Facility
Apr 22, 2022	Reliance Synergy Washer/Disinfector	The firm identified that when the electrical contactor component in the drying chamber of the Was...	Class II	Steris Corporation
Mar 22, 2022	Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 2...	Product not approved for release for US distribution	Class II	Steris Corporation
Mar 22, 2022	Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 2...	Product not approved for release for US distribution	Class II	Steris Corporation
Jan 21, 2021	OT1000 Series Orthopedic Surgical Tables	On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assem...	Class II	Steris Corporation
Dec 11, 2020	Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended f...	The electrical contactor component present in the drying chamber of the Reliance Vision Single-Ch...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 4"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 steam ...	Class II	Steris Corporation
Dec 2, 2020	Vis-U-All High Temperature Tubing 3"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 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 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 7.5"x13" 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 8"x16" Self Seal Pouch 200 pouches per box; 4 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	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 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	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 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	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	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	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	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
Nov 19, 2020	Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrumen...	STERIS has identified that certain lots of diluted 4-Zyme may contain bacteria, specifically Pseu...	Class II	Steris Corporation
Oct 7, 2020	Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid ...	Potential for cleaning solution intrusion into endoscope	Class III	Steris Corporation
Jun 26, 2020	InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ul...	A recent FDA inspection at the firm identified that the foil test performed during installation o...	Class II	Steris Corporation
Oct 22, 2019	Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 ...	Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (P...	Class II	Steris Corporation
Oct 22, 2019	Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam	The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain ...	Class II	Steris Corporation
Dec 26, 2018	ATLAS Loading Car	The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when t...	Class II	Steris Corporation
Dec 20, 2018	AMSCO 3000 Series Washer/Disinfector Model # 3052	The software in the systems may not process the cycle originally intended. This could result in d...	Class II	Steris Corporation

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.