Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach
Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.
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: FDA Class II recall of sterile surgical equipment where compromised outer packaging may breach sterility. While no illnesses or injuries have been reported, the theoretical risk of contamination in sterile medical equipment used in invasive procedures presents a significant safety concern.
Plain-English summary
Stradis Medical, LLC (dba Stradis Healthcare) is recalling the Anterior Hip Pack surgical kits because the outer bag may be perforated or torn, which could breach the sterility of the kit.
This recall affects 100 units distributed nationwide in Indiana, Texas, and Pennsylvania. The affected kits are identified by SKU/Part Number 570-2677, UDI H65257026770, and the following lot numbers: 20170461910, 20163461674, 20170462303, 20219463245, 20238464203, 20268464581, 21082472172, 21110472562, 21138473542, 21167474498, 21287478853, 21349479943.
Healthcare facilities and surgical centers that have received these kits should remove them from use immediately and contact Stradis Medical, LLC for instructions on replacement or return. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Anterior Hip Pack - Surgical Kit
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- sterility-breach
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- SKU/Part Number 570-2677
- UDI H65257026770 Lot Numbers: 20170461910
- 20163461674
- 20170462303
- 20219463245
- 20238464203
- 20268464581
- 21082472172
- 21110472562
- 21138473542
- 21167474498
- 21287478853
- 21349479943
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03