CLASS II Device recall · Reported 3 Mar 2021 · FDA Enforcement Report

Open Heart Pack recalled by DeRoyal Industries

DeRoyal Industries is recalling Open Heart Pack, distributed in Michigan, Oklahoma, Texas. The recall was initiated on 25 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022

Quantity recalled1084 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1139-2021
FDA event ID: 87218
Recalling firm: DeRoyal Industries, Powell, TN
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2021
FDA classified: 19 Feb 2021
Reported: 3 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Surgical Instruments

Timeline

25 Jan 2021	Recall initiated by company
19 Feb 2021	Classified by FDA	+25 days
3 Mar 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.

Where it was distributed

Distributors in OK, MI, and TX.

Michigan Oklahoma Texas

Questions about this recall

Why was it recalled?

Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.

Which lots are affected?

a) 89-7483.07, Lot Numbers: 48535952 exp 3/1/2021, 48613789 exp 3/1/2021, 49330297 exp 7/1/2021, 49529669 exp 8/1/2021, 49852263 exp 9/1/2021 b) 89-7483.08, Lot Numbers: 50033361 exp 11/1/2021, 50404628 exp 12/1/2021, 50783200 exp 12/1/2021 c) 89-7483.09, Lot Numbers: 51021872 exp 12/1/2021, 51121460 exp 4/1/2022, 51284373 exp 4/30/2022, 51458898 exp 4/1/2022, 51701317 exp 7/1/2022 d) 89-7483.10, Lot Numbers: 51954402 exp 9/1/2022, 52183224 exp 9/1/2022, 52413069 exp 10/1/2022, 53117579 exp 10/1/2022, 53311005 exp 11/1/2022

Where was it sold?

Distributors in OK, MI, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 87218

Reported	Class	Recall	Company	Reason	Where
3 Mar 2021	CLASS II	CV Basin Set Pack recalled by DeRoyal Industries	DeRoyal Industries	Sterility	MI, OK, TX
3 Mar 2021	CLASS II	Heart Pack recalled by DeRoyal Industries	DeRoyal Industries	Sterility	MI, OK, TX

More recalls from DeRoyal Industries

All 226

Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled	DeRoyal Industries	Sterility	Nationwide
12 Mar 2025Device	CLASS II	DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF recalled	DeRoyal Industries	Foreign Material	5 states
26 Feb 2025Device	CLASS II	DeRoyal AMG Suction Connector Tubing recalled by DeRoyal Industries	DeRoyal Industries	Packaging Defects	21 states
13 Nov 2024Device	CLASS II	DeRoyal C-section Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide
13 Nov 2024Device	CLASS II	DeRoyal Children's General Tracepack recalled by DeRoyal Industries	DeRoyal Industries	Other	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide