The Recall Desk
HighFDA (Devices)·Z-0533-2025·Announced 2024-12-04

Medline Surgical Implant Kits Recalled for Incorrect Suture Specifications

Medline is recalling 360 surgical implant and thoracotomy kits because some suture packages contain incorrect needle types, sizes, or suture diameters and lengths. The affected kits were distributed to healthcare facilities in five states.

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: This is an FDA Class II recall of surgical implant kits where incorrect suture specifications could affect surgical outcomes. Although no illnesses or injuries have been reported, these represent risk-of-harm medical devices used in cardiac and thoracic procedures where incorrect materials could compromise patient safety.

Plain-English summary

Medline Industries, LP is recalling 360 surgical implant and thoracotomy convenience kits due to incorrect suture specifications in some packages. The recalled kits include Medline Pacer Implant Packs (REF DYNJ59194A) and Medline Thoracotomy Morristown kits (REF DYNJ904220F).

Some suture packages within these kits contain the incorrect needle type, needle size, and suture diameter or length. This mismatch could compromise the proper placement of sutures during pacemaker implantation or thoracotomy procedures.

The affected kits were distributed in Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Specific lot numbers and UDI codes are available through the FDA recall notice to help healthcare facilities identify affected inventory.

Healthcare providers and facilities should check their supply inventory against the recalled lot numbers and contact Medline Industries for instructions regarding return or replacement of affected products.

The recalled product

Product
(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Implant Kits
Hazard
  • incorrect-needle-type
  • incorrect-needle-size
  • incorrect-suture-specification

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 (10)

  • (1) REF DYNJ59194A - Lot numbers 24DLA916
  • exp. 12/31/2025
  • and 24BLA030
  • exp. 11/30/2025
  • UDI-DI each 10193489573480
  • UDI-DI case 40193489573481
  • and (2) REF DYNJ904220F - Lot number 24DLA070
  • exp. 11/30/2024
  • UDI-DI each 10195327362300
  • UDI-DI case 40195327362301.

Distribution

Distributed nationwide across the United States.

Related recalls

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