Use cautionMedical device recall · FDA · Published September 18, 2023
DeRoyal Head and Neck Kit Recall: Sterile Packaging Risk
DeRoyal recalls surgical kits with potential sterile packaging damage from syringe luer tip issues. Affected lots include specific expiration dates and serial numbers.
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
“DeRoyal Head and Neck Kit Recall: Sterile Packaging Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57310-deroyal-head-and-neck-kit-recall-sterile-packaging-risk. Based on FDA recall #Z-0116-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2024%22&limit=1).
DeRoyal Industries Inc recalled DeRoyal Head and Neck procedure kits containing B.Braun Medical Norm-Ject syringes due to potential sterile packaging damage from luer tip defects, according to the FDA on September 18, 2023.
How to tell if you have it
Brand: DeRoyal
Product: DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
UDI/DI (GTIN): 74975659085
Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027
Quantity: 32 kits
Distribution: Pennsylvania
The hazard
The recall is due to the potential for the sterile packaging barrier to be damaged because of damage to the luer tip of the syringe.
Context
GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Other recent recalls include a DeRoyal Myocardial Probe recall (August 20, 2026) for incorrect needle size, a DeRoyal Covaderm Plus Dressing recall (May 18, 2026) for sterility risk, and a DeRoyal Suction Tubing recall (January 31, 2025) for inadequate suction. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), Medline Convenience Kits Recall: Sterile Packaging Risk (June 12, 2026), and Medline Eye Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).
How to tell if you have this one
Check for the lot codes 59205650 or 59496207 with expiration dates of November 1, 2027, on the DeRoyal Head and Neck procedure kit (REF 89-4473).
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for lot codes 59205650 or 59496207 with expiration date November 1, 2027 on the DeRoyal Head and Neck procedure kit (REF 89-4473).
Where it went and when
Where it was distributed
Distributed in Pennsylvania.
Listed by the agency
Not listed
FDA distribution: “Pennsylvania” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Pennsylvania.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0116-2024 (September 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0116-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.