Use caution Medical device recall · FDA · Published January 22, 2018

DeRoyal Custom Sterile Surgical Packs Recall: No Flow Risk in OPS Valve

DeRoyal recalls custom sterile surgical packs with Terumo Over Pressure Safety Valve due to reported 'No Flow' issues. Affected packs have specific lot numbers and labels.

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

🇺🇸 FDA recall #Z-0637-2018Medical device DeRoyal ›

Use caution until it’s fixed

DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

Take action

Contact the company

Recalling firmDeRoyal Industries Inc200 Debusk Ln · Powell, TN 37849-4703

✎ GovInfoNow plain-language explainer

DeRoyal is recalling custom sterile surgical packs that contain a Terumo Over Pressure Safety Valve. The recall is due to reports of 'No Flow' through this valve, which could lead to improper surgical procedures. Read more at govinfonow.com/recall/72116-deroyal-custom-sterile-surgical-packs-recall-no-flow-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/72116-deroyal-custom-sterile-surgical-packs-recall-no-flow-risk-in · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0637-2018

Cite this page

“DeRoyal Custom Sterile Surgical Packs Recall: No Flow Risk in OPS Valve.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72116-deroyal-custom-sterile-surgical-packs-recall-no-flow-risk-in. Based on FDA recall #Z-0637-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2018%22&limit=1).

The FDA announced on Jan. 22, 2018, that DeRoyal Industries Inc voluntarily recalled custom sterile surgical packs due to a hazard involving the Terumo Over Pressure Safety Valve. The agency issued recall number Z-0637-2018 for the Class II device.

How to tell if you have it

Brand: DeRoyal
Product: GEO-MED CABG PACK PGYBK A & B
REF: 89-5985.07
Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
Units affected: 181

The hazard

The recalled custom sterile surgical kits contained the Terumo Over Pressure Safety Valve. These units were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.

Context

GovInfoNow's records show DeRoyal Industries Inc has had 29 other recalls on record since June 7, 2017. Other recent recalls include a myocardial probe recall on Aug. 20, 2026, and a Covaderm Plus dressing recall on May 18, 2026. Similar recent recalls of sterile devices include a Vortex Surgical device recall on Dec. 16, 2025, and a Vortex Surgical injection kit recall on the same date.

How to tell if you have this one

Look for packs labeled 'GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO' with lot numbers 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, or 46203903.

Brand
DeRoyal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Pack Label
Look for the specific label and lot numbers listed in the recall notice to confirm if your pack is affected.

Where it went and when

Where it was distributed

Distributed in New York.

FDA distribution: “US Distribution to: NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: New York.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Jan 22, 2018Firm started the recall
Feb 16, 2018FDA classified it Class II
Feb 28, 2018Published in FDA’s Enforcement Report
Aug 19, 2020FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/72116-deroyal-custom-sterile-surgical-packs-recall-no-flow-risk-in">DeRoyal Custom Sterile Surgical Packs Recall: No Flow Risk in OPS Valve (GovInfoNow)</a>

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-0637-2018 (January 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0637-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 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.