FDA Device recall Z-0881-2023
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy…
- FDA Device
- Class II
- ongoing
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy… by Windstone Medical Packaging, citing due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0881-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-01 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
Product
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
Reason
Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
Identifiers
| code_info | Part Numbers / Product Description / UDI Code: 26000004M Custom Lasik Kit B09826000004M0 Lot Numbers 172743 175939 1787…Part Numbers / Product Description / UDI Code: 26000004M Custom Lasik Kit B09826000004M0 Lot Numbers 172743 175939 178701 AMS10411A Nasal Endoscopy Pack B098AMS10411A0 Lot Numbers 167289 171449 176800 AMS10710A Ultrasound Tray w/PDI B098AMS10710A0 Lot Numbers 165400 170502 172266 174545 178063 AMS11941 Total Knee Pack B098AMS119410 Lot Numbers 167985 172632 AMS12138B Eye Pack B098AMS12138B0 Lot Number 173532 AMS12278B Body Pack B098AMS12278B0 Lot Numbers 169016 171534 173220 174960 176107 178175 AMS12341A Hassan Pack B098AMS12341A0 Lot Number 167836 AMS12341B Hassan Pack B098AMS12341B0 Lot Numbers 170376 176035 178108 AMS12343A Meldrum Pack B098AMS12343A0 Lot Numbers 169907 173805 178357 AMS12359B Neuro Pack B098AMS12359B0 Lot Numbers 169315 174926 177785 AMS12520 Total Hip Pack B098AMS125200 Lot Number 172089 AMS12608 Extremity Pack B098AMS126080 Lot Numbers 167069 167271 171686 172416 173221 175365 AMS12610 Shoulder Pack B098AMS126100 Lot Numbers 165469 176734 179262 AMS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0881-2023%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.