The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2086-2023·Announced 2023-07-12

Medical procedure packs recalled for compromised package seals

DeRoyal Industries is recalling 4,225 custom medical procedure packs nationwide because outer package seals may be open or compromised, potentially affecting sterility of the surgical materials inside.

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: This is an FDA Class II recall involving compromised package seals that could affect the sterility of medical procedure packs. No illnesses or injuries have been reported. The hazard is sterilization compromise, which is a theoretical risk without confirmed harm, placing this at the High severity level per the rubric.

Plain-English summary

DeRoyal Industries Inc. is recalling 4,225 custom medical procedure packs due to potential for compromised outer package seals. The recalled packs include multiple surgical procedure kits used in various surgical specialties.

The outer package seal on these packs could be open or compromised, which affects the sterility of the procedure packs inside. Compromised package seals may allow contamination of the sterile surgical materials contained within the packs.

The affected packs were distributed nationwide. Multiple product variants are included in the recall, including packs used for open heart surgery, cardiac catheterization, orthopedic procedures, and other surgical specialties. Specific lot numbers have been identified for each product variant.

The recalled product

Product
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF…
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical procedure packs
Hazard
Affected units
4,225

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 '53-1941
  • GTIN 50749756864676 (cs)
  • 00749756864671 (unit)
  • Lot Numbers: 59095817
  • 59108518
  • 59132841
  • 59153079
  • 59169847
  • 59185134
  • 59216471
  • 59224383
  • b) REF '89-10045
  • GTIN 50749756980123 (cs)
  • 00749756980128 (unit)
  • Lot Numbers: 58714313
  • c) REF '89-10115
  • GTIN 50749756977901 (cs)
  • 00749756980128 (unit)
  • Lot Numbers: 58746278
  • d) REF '89-10213

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by DeRoyal Industries 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 5 products in this recall →

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