The Recall Desk
ModerateFDA (Devices)·Z-2714-2024·Announced 2024-08-28

Medline Surgical Procedure Kits Recalled for Dimensional Fit Issue

Medline is recalling 14,977 surgical procedure kits due to dimensional variations that may cause difficulty fitting into the outer canister.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a dimensional variation affecting product fit, which is a functional quality issue rather than an inherent safety risk.

Plain-English summary

Medline Industries is recalling 14,977 surgical procedure kits across multiple models due to dimensional variations in the kits. The variation has the potential to cause increased difficulty fitting the kits into their outer canister.

The affected kits include ARTHROSCOPY, BACK CDS, EXTREMITY, HAND-LF, HIP PINNING, KNEE, KNEE ARTHROSCOPY, LAMINECTOMY, LOWER EXTREMITY, MINOR EXTREMITY, PODIATRY, SHOULDER, SHOULDER ARTHROSCOPY, SPINE, TOTAL HIP, TOTAL JOINT, TOTAL KNEE, TOTAL SHOULDER, TURK-HAND, and UPPER EXTREMITY models. The kits were distributed worldwide, including to the United States, Canada, Mexico, Panama, El Salvador, Colombia, Oman, Qatar, and Singapore.

Consumers and healthcare facilities that have received these kits should review their inventory against the provided lot numbers and reference numbers. Contact Medline Industries for instructions regarding affected units.

The recalled product

Product
Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • dimensional-variation

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 (20)

  • a) REF DYNJ909699
  • UDI/DI 40195327446759 (case)
  • 10195327446758 (unit)
  • Lot Numbers: DYNJ909699
  • DYNJ909699
  • b) REF CDS984000C
  • UDI/DI 40889942011552 (case)
  • 10889942011551 (unit)
  • Lot Numbers: 22GBT604
  • 22IBI040
  • 23ABA955
  • 23DBT170
  • 23EBU747
  • 23HBB409
  • c) REF DYNJ900847A
  • UDI/DI 40888277771209 (case)
  • 10888277771208 (unit)
  • Lot Numbers: d) REF DYNJ902619G
  • UDI/DI 40195327214488 (case)
  • 10195327214487 (unit)

Distribution

Distributed nationwide across the United States.

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