Reported Dec 4, 2024 · Ongoing
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…
Karl Storz Endoscopy
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Karl Storz Endoscopy · 2151 E Grand Ave · El Segundo, CA · 90245-5017
Is this the product you have?
8 of 8 products
| Model / number | Product as published |
|---|---|
28208BKS | Aggressive Cutter, sterile, 6x 3.5 x 70 mm |
28206CBS | Full Radius Resector, sterile, 6x 5.5 x 120 mm |
28205NDS | Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm |
20205FDS | Round Burr, sterile, 6x 6.5 x 120 mm |
28205HES | Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm |
28205GDS | Finish Barrel Burr, sterile, 6x 5.5 x 180 mm |
28208IDS | Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm |
28205HDS | Aggressive Barrel Burr, sterile, 6x |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 88377N 89289N 89032N 89365N 89635N 89971N 90202N 93038N 91838N Material Number: 28206CBS UDI-DI code 2 Lot Numbers: 80066N 81369N 83233N 83478N 84444N 85877N 90894N Material Number: 28205NDS UDI-DI code 3 Lot Numbers: 83468N 84074N 83220N 84265N 84410N 85015N 84809N 85357N 86362N 87048N 91382N 93323N Material Number: 28205FDS UDI-DI code 4 Lot Numbers: 82968N 84246N 83460N 84416N 84440N 85352N 86057N 87456N 86361N 86091N 87049N 88223N 82233N 88755N 88491N 89902N 90702N 90200N 90531N 92248N 93022N 96143N 95045N Material Number: 28205HES UDI-DI code 5 Lot Numbers: 81806N 84978N 82127N 86078N 88756N 79745N 89950N 90679N 90911N 92548N-3 92548N-2 92548N-1 93707N 93027N 92955N 91032N 95051N 92995N Material Number: 28205GDS UDI-DI code 6 Lot Numbers: 82969N 83245N 84247N 84804N 85880N 85353N 87045N 90214N 86380N 90532N 93023N 91039N 95046N 95679N Material Number: 28208IDS UDI-DI code 7 Lot Numbers: 83236N 83268N 82133N 84447N 85362N 86364N 87863N 86807N 88483N 89033N 89024N 89905N 89679N 89959N 90913N 92551N-2 92552N-1 92552N-2 92551N-1 91318N 93033N 91381N 93086N 94862N Material Number: 28205HDS UDI-DI code 8 Lot Numbers: 83219N 83466N 84250N 85184N 84808N 86084N 86085N 86388N 86049N 87864N 88408N 88481N 88767N 89027N 89657N 89949N 89957N 90510N 91490N 93330N 93349N 91031N 90910N 91040N 93026N 93997N 93035N - Amount recalled
- 105 devices
Where it was sold
Why it was recalled
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
This product could cause temporary or reversible health problems — stop using it.
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