FDA Device recall Z-0526-2025

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 28205N…

FDA Device
Class II
ongoing
Published 2024-12-04

On 2024-12-04 the FDA classified a Class II recall of 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 28205N… by Karl Storz Endoscopy, citing due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0526-2025
Classification	Class II
Status	ongoing
Initiated	2024-10-11
Published	2024-12-04
Last updated	2026-09-13 11:57 UTC
Company	Karl Storz Endoscopy
Distribution	US

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

Reason

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

Identifiers

code_info	Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 883… 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-

code_info

Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 883…

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-

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0526-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.