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…
Read the official notice →- Date
- 2023-06-28
- Country
- United States
- Brand
- Karl Storz Endoscopy
- Product
- 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…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution including in the states of IN, MS, MN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-04-10
USKarl 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
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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 → - 2023-06-28
- 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 →
Other drugs & medical recalls in the United States
- 2023-07-05
- US
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey…
Packaging defect: blister packaging inadequately sealed.
- 2023-06-28
- US
Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore…
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
FDA · DeviceHeartware, Inc.Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the…Official notice → - US
Draeger Medical Systems, Inc. recalls Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C,…
The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.
FDA · DeviceDraeger Medical Systems, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, DE, FL,…Official notice → - US
Olympus Corporation of the Americas recalls Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog…
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The…
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Masimo Corporation recalls Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
TC-I tip clip sensor may produce readings outside the accuracy specification.
FDA · DeviceMasimo CorporationUS: AK , AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of SINGAPORE,…Official notice →