Lower riskMedical device recall · FDA · Published June 18, 2019
DeRoyal CRANI PACK Recall: Sterility Risk from Blunt Cannulas
DeRoyal's CRANI PACK surgical packs (REF 89-9211.07) are recalled due to potential sterility compromise from defective blunt cannulas. Affected units include Lot 49888830.
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
DeRoyal's CRANI PACK custom surgical packs (REF 89-9211.07) are being recalled because the blunt cannulas inside may have a manufacturing defect that could compromise the sterility barrier. This could lead to infections if the packs are used without proper sterility. Read more at govinfonow.com/recall/67649-deroyal-crani-pack-recall-sterility-risk-from-blunt-cannulas.
“DeRoyal CRANI PACK Recall: Sterility Risk from Blunt Cannulas.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67649-deroyal-crani-pack-recall-sterility-risk-from-blunt-cannulas. Based on FDA recall #Z-1981-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1981-2019%22&limit=1).
The FDA announced on June 18, 2019, that DeRoyal Industries Inc is recalling one custom surgical pack due to a manufacturing defect that could compromise sterility. The recall affects the DeRoyal THE RESOURCE GROUP, CRANI PACK with reference number 89-9211.07.
How to tell if you have it
Brand: DeRoyal
Product: THE RESOURCE GROUP, CRANI PACK custom surgical pack
Reference: REF 89-9211.07
Lot code: 49888830
Quantity: 108 units
The hazard
The custom surgical pack contains Cardinal Health Blunt Cannulas with a manufacturing defect in the cartridge component. This defect could compromise the sterility barrier of the product.
Context
GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Recent brand recalls include a Mayocardial Probe recall on August 20, 2026, for incorrect needle size and a Covaderm Plus Dressing recall on May 18, 2026, for sterility risk. Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (January 7, 2026) and Argon Medical Devices General Biospy Tray Recall: Sterility Risk (June 1, 2026).
How to tell if you have this one
Check for the product name 'CRANI PACK', reference number REF 89-9211.07, and lot number 49888830 on the packaging or label. These packs are sold by DeRoyal Industries Inc.
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the reference number REF 89-9211.07 and lot number 49888830 on the packaging to confirm if your pack is affected.
Where it went and when
Where it was distributed
Distributed in Oklahoma.
Listed by the agency
Not listed
FDA distribution: “US Distribution to: OK” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Oklahoma.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1981-2019 (June 18, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1981-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.