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…
Read the official notice →- Date
- 2022-11-23
- Country
- United States
- Brand
- Steris
- Product
- GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Arizona, Illinois, Tennessee,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-05-24
USSteris 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 → - 2023-01-11
- US
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…
FDA · DeviceSteris CorporationNationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZAOfficial notice → - 2022-10-19
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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
- US
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…
- 2022-06-01
- US
Steris Corporation recalls Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Product not approved for release for US distribution
Other drugs & medical recalls in the United States
- 2022-11-23
- US
Medtronic Navigation, Inc. recalls Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue…
Due to a defect in the outer pouch sterile seal
FDA · DeviceMedtronic Navigation, Inc.U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL,…Official notice → - US
Altimate Medical, Inc. recalls EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
Some EasyStand Bantam Small and Extra Small standers with the non-supine option may have been manufactured with a component that affects the operation of the leg assembly bracket to maintain the standers non-supine…
FDA · DeviceAltimate Medical, Inc.Worldwide - US distribution in the states of CA, CT, FL, LA, MI, TN, TX and…Official notice → - US
Texas Medical Technology Inc. recalls Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the…
FDA · DeviceTexas Medical Technology Inc.US Nationwide distribution in the state of FL.Official notice → - US
Howmedica Osteonics Corp. recalls Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)
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Getinge Usa Sales Inc recalls Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN.…Official notice → - US
Atrium Medical Corporation recalls Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA · DeviceAtrium Medical CorporationUS Nationwide distribution in the state of VA.Official notice →