Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions
Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall due to inadequate sterilization instructions. No illnesses or injuries reported. Per the rubric, risk-of-harm products without reported injury warrant High (3) severity, as improper sterilization methods could compromise device protection and patient safety.
Plain-English summary
Karl Storz Endoscopy is recalling metal sterilization trays used to encase and protect medical devices during sterilization. Approximately 4,933 units of various tray models were affected.
The trays were initially distributed with instructions for use that were not specific to individual tray models and did not include information about sterilization modality. A new 510(k) submission now provides model-specific instructions with sterilization modality information for the first time.
The affected products include multiple metal and wire tray models with various dimensions, including REF models 11580A, 11580B, 11580C, 11580D, 39501A1, 39501A2, 39501B2, 39501BEC, 39501C, 39501CEC, 39501F, 39501LC2, 39501X, 39501XK, 39501XP, and 39550A, manufactured by Karl Storz Endoscopy. The trays were distributed worldwide and throughout all United States.
The recalled product
- 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 Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39
- Manufacturer
- Karl Storz Endoscopy
- Hazard
- inadequate-instructions
- sterilization-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- REF/UDI-DI: 11580A/ 04048551051801
- 11580B/ 04048551051818
- 11580C/ 04048551051825
- 11580D/ 04048551051832
- 39501A1/ 04048551157619
- 39501A2/ 04048551157626
- 39501B2/ 04048551157657
- 39501BEC/ 04048551241400
- 39501C/ 04048551157671
- 39501CEC/ 04048551254158
- 39501F/ 04048551157695
- 39501LC2/ 04048551273432
- 39501X/ 04048551157756
- 39501XK/ 04048551157763
- 39501XP/ 04048551157770
- 39550A/ 04048551157879. All lots.
Distribution
Distributed nationwide across the United States.
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