Karl Storz surgical instruments recalled for sterility barrier defect
Karl Storz Endoscopy has recalled 105 surgical instruments with holes in their sterility barriers. The defect may compromise product sterility; affected devices were distributed nationwide and internationally.
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: This is an FDA Class II recall affecting sterile surgical instruments with a compromised inner barrier system. Although the potential for contamination exists, no illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury falls into the High category.
Plain-English summary
Karl Storz Endoscopy is recalling 105 surgical instruments across multiple models, including aggressive cutters (REF 28208BKS), full radius resectors (REF 28206CBS), shaver blades (REF 28205NDS), round burrs (REF 20205FDS), aggressive barrel burrs (REF 28205HES and 28205HDS), finish barrel burrs (REF 28205GDS), and semi-hooded barrel burrs (REF 28208IDS). All affected units are sterile, single-use surgical instruments.
The recall was initiated because holes have been detected in the inner barrier system of these products, which may compromise their sterility. Surgical instruments with compromised sterility barriers pose a contamination risk during medical procedures.
The affected devices were distributed worldwide with U.S. distribution across 15 states: Alabama, Florida, Iowa, Indiana, Kansas, Massachusetts, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, Texas, Tennessee, and Virginia. International distribution includes Canada and Germany. Specific lot numbers for each product reference are available from the FDA and the manufacturer.
If you have any of the recalled devices, contact Karl Storz Endoscopy immediately. Do not use the affected products. Healthcare facilities should verify lot numbers against the recall notice and segregate affected inventory from patient use.
The recalled product
- Product
- 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 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES…
- Manufacturer
- Karl Storz Endoscopy
- Affected units
- 105
Distribution
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