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…
Read the official notice →- Date
- 2024-05-22
- Country
- United States
- Brand
- Karl Storz Endoscopy
- Product
- LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide in the states of OH, CA, FL, MA, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-12-04
USKarl 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 → - 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 → - 2023-09-27
- US
Karl Storz Endoscopy recalls Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Flexible intubation endoscopes sterility assurance can not be confirmed.
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-22
- US
QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free…
Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact…
FDA · DeviceQUIDELORTHOWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
QUIDELORTHO recalls VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human…
T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact…
FDA · DeviceQUIDELORTHOWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion pump, Product Code 357009
There is a potential for cracks on the mount of the front panel of the device.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of Ohio, Wisconsin.Official notice → - US
Wishbone Medical, Inc. recalls WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
FDA · DeviceWishbone Medical, Inc.US distribution to Florida, New Jersey and Connecticut.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Namic FLUID DELIVERY SET, REF 91300040
Products have a lack of sterility assurance.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC,…Official notice → - US