Halyard Cardiac Cath Pack Kit Syringe Adapter Unwinding Risk
AVID Medical recalls Halyard Cardiac Cath Pack kits (Models EAMC1000-05, WAFB208-02) due to risk that a Medline syringe rotating adapter may unwind during use, causing loose or full disconnection between the syringe and manifold.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which per the rubric mandates a minimum severity score of 4. The potential for disconnection of a critical cardiac catheterization component during medical use poses significant risk of harm, meeting the Severe threshold.
Plain-English summary
AVID Medical, Inc. is recalling Halyard Cardiac Cath Pack kits (Model Numbers EAMC1000-05 and WAFB208-02) due to a potential risk that a Medline syringe rotating adapter may unwind during use.
If the adapter unwinds, a loose connection or complete disconnection may occur between the syringe and manifold. This disconnection could compromise the integrity of the medical procedure.
The recall affects 222 kits distributed to medical facilities in Florida, Illinois, Missouri, Mississippi, North Carolina, Nebraska, and Texas. Affected lot numbers include: Model EAMC1000-05 (lots 1573593, 1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306, 1675159) and Model WAFB208-02 (lots 1615954, 1653009).
Healthcare providers and medical facilities using these kits should cease use immediately and contact AVID Medical, Inc. for guidance on replacement or proper handling of affected units.
The recalled product
- Product
- Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 222
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 (12)
- 1. Model Number: EAMC1000-05. UDI-DI (Kit Lot Numbers): 10809160377314 (1573593
- 1583827
- 1609541
- 1609725
- 1612134
- 1612516
- 1619132
- 1623384
- 1627013
- 1635459
- 1672306
- 1653009).
Distribution
Part of a larger recall action
This product is one of 10 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 15 Laparoscopic Prostatectomy Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
Same hazard · connector failure
See all →- ModerateDonJoy IceMan cold therapy unit recall due to broken connector
FDA (Devices) · 2026-05-20
- ModerateDonJoy IceMan Classic Cube cold therapy unit connector defect recall
FDA (Devices) · 2026-05-20
- ModerateDonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Fault Recall
FDA (Devices) · 2026-05-20
- HighLincoln Corsair rearview cameras can take in water at the connectors
NHTSA · 2025-08-08
- HighMEDLINE Epidural and Spinal Anesthesia Procedure Kits: Connector Insertion Issue
FDA (Devices) · 2024-12-04
Similar recalls
- SevereMedline cath lab packs recalled over syringe rotating adaptor disconnection
FDA (Devices) · 2026-04-15
- SevereMedline CVOR angiography packs recalled over syringe adaptor unwinding risk
FDA (Devices) · 2026-04-15
- SevereMedical Action Industries Pack Cath BHH Catheter Kit Recall
FDA (Devices) · 2026-05-13
- SevereMedline cardiac catheterization kits recalled over syringe adaptor unwinding
FDA (Devices) · 2026-04-15
- SevereCoronary angio packs recalled over Medline syringe rotating adaptor defect
FDA (Devices) · 2026-05-13
- SevereMedline custom manifold kits recalled over syringe adaptor unwinding risk
FDA (Devices) · 2026-04-15