Recall archive
54 recalls · page 2 of 3
Reported Dec 11, 2019
Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 20, 2019
AMSCO 3000 Series Washer/Disinfector Model # 3052
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 20, 2019
ATLAS Loading Car
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in…
FDA (openFDA device enforcement)
Reported Sep 12, 2018
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not…
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical Low Level alarm, intended to prevent the user from…
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Reason for recall — On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate following steam processing…
29 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 21, 2016
Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The Drager Pendula spring arm device has a set of screws located on the spring arm that were not properly secured with Loctite and may become loose.
FDA (openFDA device enforcement)
Reported Jul 27, 2016
OT1000 Series Orthopedic Surgical Tables
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Reason for recall — STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
FDA (openFDA device enforcement)
Reported Mar 23, 2016
Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — The firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port rather than two…
FDA (openFDA device enforcement)
Reported Jan 13, 2016
AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — The firm discovered that information printed on the quick reference magnet is incorrect; specifically, Fahrenheit to Celsius temperature conversions…
FDA (openFDA device enforcement)
Reported Dec 16, 2015
Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corp.
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states…
FDA (openFDA drug enforcement)
Reported Nov 11, 2015
AMSCO 400 and AMSCO C Small Steam Sterilizers
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Steris Corporation
Matched: Brand — In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot…
FDA (openFDA device enforcement)
Reported May 6, 2015
Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 14, 2015
Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Reason for recall — STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.
FDA (openFDA device enforcement)
Reported Nov 19, 2014
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignment during extreme table articulation, excessive side…
FDA (openFDA device enforcement)
Reported Jul 16, 2014
The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details · Reason for recall — STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. If one…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2014
Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product details — Potential for the welded seam in affected monitor spring arms to crack and/or break.
FDA (openFDA device enforcement)
Reported Mar 19, 2014
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details · Reason for recall — STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as…
FDA (openFDA device enforcement)
Reported Jan 8, 2014
VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details · Reason for recall — STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2013
AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mobile, wheeled transportation unit utilized to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand — The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
FDA (openFDA device enforcement)
Reported Nov 13, 2013
Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details · Reason for recall — Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component…
FDA (openFDA device enforcement)
Reported Oct 2, 2013
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI…
FDA (openFDA device enforcement)
Reported Jul 31, 2013
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing…
FDA (openFDA device enforcement)
Reported Jul 3, 2013
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Steris Corporation
Matched: Brand · Product · Product details — During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device…
FDA (openFDA device enforcement)
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