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.
Read the official notice →- Date
- 2024-10-02
- Country
- United States
- Brand
- Karl Storz Endoscopy
- Product
- Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-01-22
USKarl 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
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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 → - 2024-05-22
- US
Karl Storz Endoscopy recalls LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then…
FDA · DeviceKarl Storz EndoscopyWorldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX,…Official notice → - 2024-04-10
- US
Karl Storz Endoscopy recalls Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Inadequate reprocessing validation evidence
FDA · DeviceKarl Storz EndoscopyUS Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA,…Official notice → - 2023-12-27
- US
Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
FDA · DeviceKarl Storz EndoscopyUS: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI,…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-02
- US
Becton Dickinson & Co. recalls BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically…
Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate treatment of infections caused by E. coli,
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice → - US
Waldemar Link GmbH & Co. KG (Corp. Hq.) recalls LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break…
FDA · DeviceWaldemar Link GmbH & Co. KG (Corp. Hq.)US Nationwide distribution in the states of FL, KS, MI, NJ, VA.Official notice → - US
American Contract Systems, Inc. recalls Pacemaker, COPM11B; Medical convenience kit
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance…
FDA · DeviceAmerican Contract Systems, Inc.US Nationwide distribution in the states of MO, MN, MA, OH, NE.Official notice → - US
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If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion…
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GE Healthcare recalls GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
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Centinel Spine, Inc. recalls prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
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