Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product…
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Read the official notice →- Date
- 2026-04-01
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product Description: The…
- Classification
- Class II
- Units
- Worldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Olympus Corporation of the Americas recalls
- 2026-04-29
USOlympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →- US
Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
FDA · DeviceOlympus Corporation of the AmericasInternational distribution in the countries of Australia, Japan, Hong Kong,…Official notice → - 2026-04-08
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2026-04-01
- US
Olympus Corporation of the Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
- 2026-03-11
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System -…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards…
FDA · DeviceOlympus Corporation of the AmericasInternational distribution in the country of Canada, Germany, Singapore,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be…
Potential for rubber fragment detachment during use.
Other drugs & medical recalls in the United States
- 2026-04-01
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are…
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH,…Official notice → - US
Medline Industries, LP recalls Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL…
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension.…
FDA · DeviceMedline Industries, LPDomestic distribution nationwide US. International distribution to Mexico and…Official notice → - US
CareFusion 303, Inc. recalls BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
FDA · DeviceCareFusion 303, Inc.Worldwide distribution: U.S.(Nationwide) to states of: AL, AR, AZ, CA, CO, CT,…Official notice → - US
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven…
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead…
FDA · DeviceTandem Diabetes Care, Inc.International distribution in the countries of Czech Republic, Slovakia.Official notice → - US
Medtronic MiniMed, Inc. recalls MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS…
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
FDA · DeviceAMO Puerto Rico Manufacturing, Inc.U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR,…Official notice →