The Recall Desk
HighFDA (Devices)·Z-1140-2021·Announced 2021-03-03

DeRoyal Heart Pack Recall Due to Non-Sterile Sternum Saw Blades

DeRoyal Industries is recalling Heart Packs containing non-sterile sternum saw blades. The affected surgical saw blades are marked with a green non-sterile sticker.

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: The recall involves a medical device where the hazard (non-sterile blades) poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DeRoyal Industries Inc is recalling 776 Heart Packs, which are custom surgical procedure packs. The specific reference numbers involved are 89-9194.07, 89-9194.09, 89-9194-10, and 89-9194-11. The recall is necessary because the sternum saw blades included in these procedure packs are not sterile.

The affected surgical saw blades are identified by a green non-sterile sticker. The source text does not report any illnesses, injuries, or deaths associated with this recall. The agency has classified this as a Class II recall.

The products were distributed to distributors in Oklahoma, Michigan, and Texas. Specific lot numbers and expiration dates are listed in the structured product information. Consumers and healthcare providers should check their inventory for these specific reference numbers and lot numbers to identify affected units.

The recalled product

Product
Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Surgical Instruments
Hazard
Affected units
776

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 (17)

  • a) 89-9194.07
  • Lot Numbers
  • 47782581 exp 5/1/2021 b) 89-9194.09
  • Lot Numbers: 50224694 exp 9/1/2023
  • 50326092 exp 9/1/2023
  • 50582301 exp 9/1/2023
  • 50795307 exp 11/1/2023
  • 51008862 exp 11/1/2023
  • 51153103 exp 11/1/2023 c) 89-9194-10
  • Lot Numbers: 51434221 exp 11/1/2023
  • 51881522 exp 11/1/2023 d) 89-9194-11
  • Lot Numbers: 52175785 exp 8/1/2022
  • 52849153 exp 11/1/2023
  • 53220664 exp 2/1/2025
  • 53327306 exp 2/1/2025
  • 53409521 exp 9/1/2023
  • 53565355 exp 12/1/2024

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

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Same hazard · non sterile

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