Karl Storz Endoscopy recalls HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…
Due to incorrect inside packaging label for eyepiece.
Read the official notice →- Date
- 2026-10-07
- Country
- United States
- Brand
- Karl Storz Endoscopy
- Product
- HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL STORZ HOPKINS¿ and HOPKINS¿ II telescopes are to be used for…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of AZ, CA and MO.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Karl Storz Endoscopy recalls
- 2026-07-29
USKarl Storz Endoscopy recalls Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI,…Official notice →- 2025-02-05
- US
Karl Storz Endoscopy recalls KARL STORZ - ENDOSKOPE, REF: 27010L, Uretero-Renoscope, 7 Fr., 43cm, NON STERILE, RxONLY, CE 0123
Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
- 2025-01-22
- US
Karl Storz Endoscopy recalls Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
FDA · DeviceKarl Storz EndoscopyUS: AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN,…Official notice → - 2024-12-04
- US
Karl Storz Endoscopy recalls 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF…
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
FDA · DeviceKarl Storz EndoscopyWorldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS,…Official notice → - 2024-11-20
- US
Karl Storz Endoscopy recalls Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY,…Official notice → - 2024-10-02
- US
Karl Storz Endoscopy recalls Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
Other drugs & medical recalls in the United States
- 2026-10-14
- US
- 2026-10-07
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
The potential for falsely elevated results.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Wright Medical Technology, Inc. recalls CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the…
FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the states of FL, TX, PA, CA, ID, MI, OK, TN,…Official notice → - US
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965…
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA,…Official notice → - US
Penumbra Inc. recalls Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System (RED 62 Reperfusion Catheter) Model/Catalog…
Due to manufacturing issues reperfusion catheters may fracture.
FDA · DevicePenumbra Inc.US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX,…Official notice → - US
Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version…
A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous…