The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0443-2025·Announced 2024-11-20

Halyard Pacemaker Drape Surgical Instruments Recalled for Loose Metal Flakes

AVID Medical recalls Halyard Pacemaker Drape surgical instruments because metal flakes may detach from sponge forceps and towel clamps. Loose metal fragments could enter surgical sites undetected and cause local or foreign body reactions.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 involving risk of surgical site contamination from metal fragments. Source explicitly states no illnesses or injuries reported; the hazard remains theoretical based on potential for metal flakes to become foreign bodies in surgical fields.

Plain-English summary

AVID Medical, Inc. has recalled Halyard Pacemaker Drape surgical instrument kits (Model VAST020-06) distributed nationwide. The recall involves sponge forceps and towel clamps in lots 1588570 and 1596857 that may shed small metal flakes.

The metal flakes can potentially detach from the surgical instruments during use and enter a patient's surgical site undetected. If metal fragments contaminate the surgical field, they may cause local tissue reactions or reactions to the presence of a foreign body. The FDA classified this as a Class II recall.

Healthcare facilities and medical professionals using these instrument kits should cease use of the affected lots. Contact AVID Medical or the FDA for instructions on replacement or return of the recalled equipment. No illnesses or injuries have been reported in connection with this hazard to date.

The recalled product

Product
Halyard PACEMAKER DRAPE - Medical convenience kits Model Number: VAST020-06
Manufacturer
AVID Medical, Inc.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
33

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 (2)

  • GTIN: 10809160333327 Lot Number: 1588570
  • 1596857

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 73 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 73 products in this recall →

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