Steris Corporation recalls VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of…
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others…
Read the official notice →- Date
- 2023-01-11
- Country
- United States
- Brand
- Steris
- Product
- VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of…
- Classification
- Class II
- Units
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Steris recalls
- 2024-01-03
USSteris Corporation recalls Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors Model # Model…
Identification label on affected hookups could become illegible over time due to the label's ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately…
FDA · DeviceSteris CorporationDomestic distribution nationwide. Foreign distribution to Australia Canada…Official notice →- 2023-05-24
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Steris Corporation recalls Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH83062
In the remote occurrence in which the electrical contactor component present in the drying chambers of the Reliance Vision Multi-Chamber Washer/Disinfector malfunctions, the heating elements in the drying chamber could…
FDA · DeviceSteris CorporationWorldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of:…Official notice → - 2023-05-10
- US
Steris Corporation recalls Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical…
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
FDA · DeviceSteris CorporationWorldwide - US Nationwide distribution including Puerto Rico and the countries…Official notice → - 2022-11-23
- US
Steris Corporation recalls GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or…
Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which…
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of Arizona, Illinois, Tennessee,…Official notice → - 2022-10-19
- US
Steris Corporation recalls 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, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking…
FDA · DeviceSteris CorporationDistribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan,…Official notice → - 2022-06-15
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Steris Corporation recalls Reliance Synergy Washer/Disinfector
The firm identified that when the electrical contactor component in the drying chamber of the Washer/Disinfector malfunctions, the heating elements in the drying chamber could overheat, eventually resulting in smoke…
Other drugs & medical recalls in the United States
- 2023-01-11
- US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone…
Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- US
Beaver Visitec International, Inc. recalls Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part…
Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
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Beckman Coulter, Inc. recalls BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN…
FDA · DeviceBeckman Coulter, Inc.US and Canada, Brazil, Korea, Mexico, Puerto Rico, TaiwanOfficial notice → - US
Medtronic MiniMed recalls Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not…
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