Karl Storz Endoscopy recalls Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA…
To ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible endoscopes with lumen diameters greater-than-or-equal to 1.2mm and…
Read the official notice →- Date
- 2022-01-05
- Country
- United States
- Brand
- Karl Storz Endoscopy
- Product
- Karl Storz Udel Sterilization Tray Instructions for Use, Tray Part Number/Description: 39301ACTS/CAMERA TRAY (STERRAD, INLINE CAMERA…
- Classification
- Class II
- Units
- US: AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-27
USKarl 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 →- 2023-06-28
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Karl Storz Endoscopy recalls Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal…
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes…
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of IN, MS, MN,…Official notice → - US
Karl Storz Endoscopy recalls KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes…
FDA · DeviceKarl Storz EndoscopyWorldwide - US Nationwide distribution including in the states of AK, AR, AZ,…Official notice → - 2022-06-15
- US
Karl Storz Endoscopy recalls STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF…
The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.
FDA · DeviceKarl Storz EndoscopyWorldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-05-18
- US
Karl Storz Endoscopy recalls 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
FDA · DeviceKarl Storz EndoscopyU.S. Nationwide distribution in the states of FL, KY, LA, MA, MI, MO, MT, NC,…Official notice → - 2021-11-10
- US
Karl Storz Endoscopy recalls FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of…
FDA · DeviceKarl Storz EndoscopyUS: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN,…Official notice →
Other drugs & medical recalls in the United States
- 2022-01-12
- US
ULTRAtab Laboratories, Inc. recalls PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined…
CGMP Deviations: failed stability results, inadequate laboratory investigations,
FDA · DrugULTRAtab Laboratories, Inc.Product was distributed to one customer who may have further distributed the…Official notice → - US
Lupin Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC…
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
- 2022-01-05
- US
AMO Manufacturing USA, LLC recalls iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive…
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations.…
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Siemens Medical Solutions USA, Inc recalls ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic…
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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on…
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