Recall record at a glance
| Official record | Z-0526-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Karl Storz Endoscopy |
| Report date | Dec 4, 2024 |
| Recall initiation date | Oct 11, 2024 |
| Quantity | 105 devices |
| Location | El Segundo, CA, United States |
Official product description
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, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
Why the product was recalled
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
Distribution information
Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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