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STERIS CORPORATION · Model Lighthandle Cover · UDI-DI 50724995156393

LRP
10
510(k) clearances
461
Adverse events (1 deaths)
110
Recalls
280
Facilities

Description

The STERIS Harmony Surgical Light Handle Tray, Bulk Pack is used to maintain the shape of the bezel Bowl during sterilization and the packagin process.

Recalls

DateFirmReason
2026-08-19Cardinal Health 200, LLCKits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the pati
2026-08-10Cardinal Health 200, LLCThe kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient
2026-07-29Cardinal Health 200, LLCThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is
2026-06-12Medline Industries, LPThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi
2026-05-21Medline Industries, LPThe kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o
2026-03-16Medline Industries, LPMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.