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…
Read the official notice →- Date
- 2022-10-19
- Country
- United States
- Brand
- Steris
- Product
- Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- Classification
- Class II
- Units
- Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
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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 → - 2022-11-23
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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 → - 2022-06-15
- 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
- 2022-10-19
- US
Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
FDA · DeviceJohnson & Johnson Surgical Vision, Inc.Worldwide Distribution. US states of AL, AR, AZ, CA, CO, DE, FL, GA, HI, IL…Official notice → - US
Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight…
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LUMINOSTICS, INC dba CLIP HEALTH recalls Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.
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Olympus Corporation of the Americas recalls Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters…
FDA · DeviceOlympus Corporation of the AmericasDomestic distribution nationwide. Foreign distribution to Canada and Japan.Official notice → - US
American Contract Systems, Inc. recalls COVID Test Kit Nonsterile
Kit incorrectly labeled for use with COVID testing and should not be used with any SARS-Co-V2 device.
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Hobbs Medical, Inc. recalls Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and…
FDA · DeviceHobbs Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice →