Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
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 device with no reported illnesses, hospitalizations, or deaths. The hazard involves loose metal flakes that could contaminate a surgical site, creating a risk of foreign body reactions. Per the rubric, risk-of-harm products without reported injury receive a High severity score.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard OPEN HEART PACK MAIN surgical convenience kits (Model ESJH003-02, Lot 1597931). The recall affects 114 units distributed nationwide in the United States.
Sponge forceps and towel clamps included in these kits may have small loose metal flakes. These flakes could potentially detach from the instruments during use and enter a patient's surgical site undetected.
Metal flakes in a surgical site may cause local tissue reactions or foreign body reactions. Although no illnesses or injuries have been reported to date, this hazard poses a potential risk during surgical procedures.
If you have received these kits, stop using them immediately and contact AVID Medical, Inc. Healthcare providers and facilities should check their inventory and remove any kits with this lot number from service. Return the kits to the manufacturer per instructions.
The recalled product
- Product
- Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-flakes
- foreign-body
- surgical-site-contamination
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 (1)
- GTIN: 10809160355725 Lot Number: 1597931
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