FDA Device recall Z-0755-2015
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipul…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipul… by Stryker Endoscopy, citing the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethyl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0755-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-17 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
Product
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Reason
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Identifiers
| code_info | 42796 42801 42802 42804 43268 44023 44024 1192011 143481 0200156B 0244656B 0245398C 0246061C 0246312C 024…42796 42801 42802 42804 43268 44023 44024 1192011 143481 0200156B 0244656B 0245398C 0246061C 0246312C 0246366C 0246986C 3222012 0341249C 0344478C 04132012E 0441343C 0441354C 0441355C 0444499C 0444505D 0445113C 0542481D 0542486D 0542488D 0542514D 06272013E 0641983D 0641985D 0641990D 0641991D 0641993D 0641996D 0641998D 0641999D 0642003D 0647975D 06CON02508 06CON05664 06CON06127 06CON08812 07232013E 7282014 0742752D 0742755D 0744892D 0744893D 0744894D 0744895D 0744899D 0744902D 0744905D 0744907D 0744908D 0744910D 0744911D 08012013E 08022013E 0812011E 8122010 08152013E 08292013E 0841786D 0842288D 8422890 0842290D 0842292D 0842294D 0842298D 09192013E 0940016D 0940020D 0940023D 0940026D 0940029D 0940032D 0940038D 0940043D 0940049D 0940053D 0940059D 0940066D 0940072D 0940076D 0940081D 0940089D 0940094D 0940097D 0940103D 0940109D 0940115D 0944842D 0944843D 0944848D 0944850D 0944853D 0944857D 09 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0755-2015%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.