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Lower risk Medical device recall · FDA · Published January 25, 2021

DeRoyal Open Heart Pack Surgical Packs: Non-Sterile Sternum Saw Blades

DeRoyal recalls custom surgical procedure packs with non-sterile sternum saw blades marked by green sticker. These packs may cause infection if used in surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1139-2021Medical deviceDeRoyal ›
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Contact the company

Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703
✎ GovInfoNow plain-language explainer

DeRoyal is recalling custom surgical procedure packs that include sternum saw blades with non-sterile stickers. Using these packs during surgery could lead to infections due to unsterile blades. Read more at govinfonow.com/recall/63351-deroyal-open-heart-pack-surgical-packs-non-sterile-sternum-saw.

Source Summary by GovInfoNow · govinfonow.com/recall/63351-deroyal-open-heart-pack-surgical-packs-non-sterile-sternum-saw · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1139-2021

Cite this page

“DeRoyal Open Heart Pack Surgical Packs: Non-Sterile Sternum Saw Blades.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63351-deroyal-open-heart-pack-surgical-packs-non-sterile-sternum-saw. Based on FDA recall #Z-1139-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1139-2021%22&limit=1).

The FDA announced on Jan. 25, 2021, that DeRoyal Industries Inc is recalling Open Heart Pack custom surgical procedure packs because the included sternum saw blades are not sterile. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: DeRoyal
  • Product: Open Heart Pack, Custom surgical procedure packs
  • REF numbers: 89-7483.07, 89-7483.08, 89-7483.09, 89-7483.10
  • Lot Numbers: 48535952, 48613789, 49330297, 49529669, 49852263 (REF 89-7483.07); 50033361, 50404628, 50783200 (REF 89-7483.08); 51021872, 51121460, 51284373, 51458898, 51701317 (REF 89-7483.09); 51954402, 52183224, 52413069, 53117579, 53311005 (REF 89-7483.10)
  • Distribution: Distributors in OK, MI, and TX
  • Units affected: 1084 packs

The hazard

The sternum saw blades within the procedure packs are not sterile, indicated by a green non-sterile sticker on the surgical saw blade. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Other recent recalls of similar products include Kii Low Profile Bladed Dual Pack Recall (Dec. 11, 2025), AVID Medical Halyard Drape Pack Kit: Unsterilized Pouches Recalled (April 30, 2026), and Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026).

How to tell if you have this one

Check for Open Heart Packs with reference numbers a) 89-7483.07 through d) 89-7483.10. Look for green stickers on the sternum saw blades indicating non-sterile status.

  • Brand
    DeRoyal
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distributors in OK, MI, and TX.
Recall numberProduct, codes & lotsQuantity
Z-1138-2021CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.; a) 89-7935.11, Lot codes: 48285959 exp 12/21/2022 b) 89-7935.12, Lot codes: 49057260 exp 5/1/2023, 49239952 exp 4/1/2023, 49481001 exp 6/1/2023, 49603726 exp 8/1/2023, 49864125 exp 7/1/2021 c) 89-7935.13, Lot codes: 50404644 exp 11/1/2021, 50698398 exp 11/1/2023 d) 89-7935.14, Lot codes: 5125317 exp 6/1/2022 e) 89-7935.15, Lot codes: 51305461 exp 2/1/2024, 51983318 exp 2/1/2024 f) 89-7935.16, Lot codes: 53324463 exp 12/1/2024309 packs
Z-1139-2021Open 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.; 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 11/1/20221084 packs
Z-1140-2021Heart 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.; 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 12/1/2024776 packs
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify your Open Heart Pack by reference numbers and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 3 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: yesMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “Distributors in OK, MI, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Michigan, Oklahoma, Texas.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Jan 25, 202112. FDA classified it Class II: Feb 19, 202123. Published in FDA’s Enforcement Report: Mar 3, 202134. FDA terminated the recall: Jul 21, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1139-2021 (January 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1139-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA