Karl Storz Grasping Forceps Recalled for Inadequate Reprocessing Validation
FDA recalls 190 units of Karl Storz grasping forceps due to inadequate evidence validating safe reprocessing and sterilization of the instruments.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 affecting surgical instruments used in invasive endoscopic procedures. The hazard—inadequate validation of reprocessing procedures—poses a risk of inadequate sterilization and subsequent patient contamination or infection. No illnesses or injuries are documented in the source.
Plain-English summary
Karl Storz has issued a Class II recall of its REF 11003MB Grasping Forceps (Flexible 1 mm) affecting 190 units distributed nationwide across 27 U.S. states.
The FDA determined that the manufacturer did not provide adequate evidence validating the effectiveness of the reprocessing procedure for these instruments. Reprocessing—which includes cleaning and sterilization—is critical to ensure the forceps are safe for reuse in endoscopic procedures. Without proper validation, there is a risk that instruments may not be adequately sterilized before reuse, potentially exposing patients to contamination or infection.
Affected healthcare facilities should contact Karl Storz Endoscopy for instructions on product management. Clinicians and hospital administrators should verify whether their facility has received affected units and follow the manufacturer's guidance.
The recalled product
- Product
- Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 190
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 (1)
- UDI: 04048551050255/ All Lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Karl Storz Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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