Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Reported: December 24, 2025 Initiated: November 14, 2025 #Z-0927-2026
Product Description
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Reason for Recall
Potential for incomplete seal on header bag.
Details
- Recalling Firm
- AVID Medical, Inc.
- Units Affected
- 240 units
- Distribution
- US distribution to GA, IL, NE, MD.
- Location
- Toano, VA
Frequently Asked Questions
What product was recalled? ▼
Halyard, EP LAB PK. Catalog Number: ESJH009-03.. Recalled by AVID Medical, Inc.. Units affected: 240 units.
Why was this product recalled? ▼
Potential for incomplete seal on header bag.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Moderate. Recall number: Z-0927-2026.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11