FDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes
Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of surgical instrument kits containing a recalled component. No illnesses or injuries are reported. The score reflects the risk-of-harm nature of surgical medical devices combined with the absence of reported harm.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 9,489 custom surgical instrument disposable kits because the kits contain 3M Steri-Drape Surgical Drapes that 3M Healthcare has recalled. These kits are designed for various surgical procedures and include multiple product types identified by specific part numbers and UDI codes.
The recalled kits were distributed worldwide and to multiple U.S. states including Arizona, California, Colorado, Connecticut, Florida, Guam, Indiana, North Carolina, New Jersey, Nevada, Oklahoma, Pennsylvania, Tennessee, Texas, and Wisconsin, as well as to Canada.
The recalled product
- 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 AMS12341
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 9,489
Distribution
Related recalls
Same manufacturer · Windstone Medical Packaging, Inc.
See all →- HighRitmed Neurological Sponges Recalled Due to Potential Endotoxin Level Variability
FDA (Devices) · 2026-08-05
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- HighMedical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
Same hazard · recalled component
See all →- HighMEDLINE medical convenience kits recalled for defective component
FDA (Devices) · 2024-12-11
- HighMedline recalls surgical kits containing Stryker smoke evacuation pencil component
FDA (Devices) · 2024-12-11
- ModerateMedline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
- ModerateDeRoyal SPINE PACK procedure kits recalled due to recalled Steri Drapes
FDA (Devices) · 2022-12-21
- ModerateDeRoyal Spinal Fusion Packs Recalled Due to Affected Sterile Drapes
FDA (Devices) · 2022-12-21