medical Class II Updated 2024-12-04

Karl Storz Endoscopy recalls 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x

Recalled 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, 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

Hazard / Issue

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 88377N 89289N 89032N 89365N 89635N 89971N 90202N 93038N 91838N Material Number: 28206CBS UDI-DI code: Lot Numbers: 80066N 81369N 83233N 83478N 84444N 85877N 90894N Material Number: 28205NDS UDI-DI code: Lot Numbers: 83468N 84074N 83220N 84265N 84410N 85015N 84809N 85357N 86362N 87048N 91382N 93323N Material Number: 28205FDS UDI-DI code: 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: 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: Lot Numbers: 82969N 83245N 84247N 84804N 85880N 85353N 87045N 90214N 86380N 90532N 93023N 91039N 95046N 95679N Material Number: 28208IDS UDI-DI code: 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: 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

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