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
Dec 20, 2018	AMSCO 5000 Series Washer/Disinfector Model # 5052	The software in the systems may not process the cycle originally intended. This could result in d...	Class II	Steris Corporation
Jul 26, 2018	AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Syst...	There is the potential for a scenario where a punctured cup of sterilant expires while the system...	Class II	Steris Corporation
May 23, 2018	Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003...	The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical ...	Class II	Steris Corporation
Sep 28, 2017	V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)	Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes p...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 18"x22" Self Seal Pouch 100 pouches per box; 5 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 13"x18" Heat Seal Pouch 100 pouches per box; 4 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 3.5"x22" Heat Seal Pouch 200 pouches per box; 5 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 8"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per c...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 16"x16" Heat Seal Pouch 100 pouches per box; 5 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 4.5"x11" Heat Seal Pouch 200 pouches per box; 5 boxes per...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 10"x15" Heat Seal Pouch 100 pouches per box; 5 boxes per ...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Jun 15, 2017	Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca...	On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All...	Class II	Steris Corporation
Oct 5, 2016	Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The...	The Drager Pendula spring arm device has a set of screws located on the spring arm that were not...	Class II	Steris Corporation
May 23, 2016	OT1000 Series Orthopedic Surgical Tables	STERIS has identified that the pivot pin assembly located on the table top may become loose preve...	Class II	Steris Corporation
Dec 4, 2015	Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC...	The firm discovered that one of the hysteroscope models listed for processing in four existing Qu...	Class II	Steris Corporation
Nov 20, 2015	AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the ...	The firm discovered that information printed on the quick reference magnet is incorrect; specific...	Class II	Steris Corporation
Sep 3, 2015	AMSCO 400 and AMSCO C Small Steam Sterilizers	In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadver...	Class III	Steris Corporation
Feb 19, 2015	Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ...	Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri...	Class II	Steris Corporation
Feb 19, 2015	AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small...	STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will ...	Class II	Steris Corporation
Nov 26, 2014	Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmon...	STERIS has learned that groups of LED lights (modules) contained within the vLED light head may i...	Class II	Steris Corporation
Oct 10, 2014	The 5085 is a general surgical table with high patient weight capacity, exten...	The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignmen...	Class II	Steris Corporation
Jun 30, 2014	Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ...	STERIS has identified that deformation of the washers door handle pin may occur when the door ha...	Class III	Steris Corporation
Jun 27, 2014	The STERIS 4085 General Surgical Table Product Usage: is an electro-hydra...	STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifol...	Class II	Steris Corporation
Apr 4, 2014	Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harm...	Potential for the welded seam in affected monitor spring arms to crack and/or break.	Class II	Steris Corporation
Dec 19, 2013	VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, ...	STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCe...	Class II	Steris Corporation
Nov 21, 2013	SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS ...	Customers indicated fluctuations in environmental conditions sites and gradual degradation/deform...	Class II	Steris Corporation
Oct 18, 2013	AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mob...	The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or ma...	Class II	Steris Corporation
Sep 10, 2013	VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER...	STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ...	Class II	Steris Corporation
Aug 29, 2013	Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley...	The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle o...	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.