Olympus Corporation of the Americas recalled 1,918 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall follows concerns that devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
Devices which did not undergo thermoforming could deform and lose performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC412Q-0215. It was distributed worldwide, including 413 units in the US and 1,505 units internationally. The recall affects all lots with a valid expiration date.
Devices that did not undergo proper thermoforming could deform, presenting a high risk of loss of performance during use. This could lead to complications during medical procedures that utilize the device.
There have been no reported injuries or deaths associated with this recall. However, the potential for device failure could have serious implications in clinical settings.
Patients and healthcare providers should stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and follow the recall guidelines provided.
For more information, contact Olympus Corporation of the Americas at [insert phone number]. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1282-2026.
Get instant alerts for recalls that affect you. Free forever.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Pro Numb Tattoo Numbing Spray was recalled on February 2, 2026 due to cGMP deviations. The product, containing 4% lidocaine, is distributed by Pro Numb Tattoo Numbing Spray LLC. Consumers should stop using it immediately and contact the company for further guidance.
Pro Numb Tattoo Numbing Spray was recalled due to cGMP deviations. The recall affects products distributed nationwide in the USA. Consumers should stop using the spray immediately and contact Pro Numb Tattoo Numbing Spray LLC for guidance.