DeRoyal recalls specific lot of Angio Cath Removal Tray (REF 89-9936.02) due to mislabeled 0.5% Bupivacaine instead of 1% Lidocaine. Affected units contain lot numbers 54368716 expiring 6/01/2022.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
“DeRoyal Angio Cath Removal Tray Recall: 0.5% Bupivacaine Mislabeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62539-deroyal-angio-cath-removal-tray-recall-0-5-bupivacaine-mislabeling. Based on FDA recall #Z-1834-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1834-2021%22&limit=1).
The FDA announced on May 14, 2021, that DeRoyal Industries Inc is recalling the DeRoyal Angio Cath Removal Tray due to mislabeling of its lidocaine component. The product contains 0.5% Bupivacaine instead of the labeled Hospira Pfizer 1% Lidocaine.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling. The product is 0.5% Bupivacaine.
Context
GovInfoNow's records show DeRoyal Industries Inc has 29 other recalls on record since June 7, 2017. Recent DeRoyal recalls include a myocardial probe recall on Aug. 20, 2026, and a Covaderm Plus dressing recall on May 18, 2026. Other recent recalls of similar products include Bard Groshong NXT Catheter Recall (May 21, 2026), Bard Provena Midline Catheters Recall (May 21, 2026), and Bard PowerMidline Catheter Recall (May 21, 2026).
How to tell if you have this one
Check for the product name 'DeRoyal Angio Cath Removal Tray' with reference number 89-9936.02. The affected lot number is 54368716, expiring June 1, 2022.
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 I
Status
Terminated
Distribution
US Nationwide distribution to the states of MS, VA, LA, and NY.
Recall number
Product, codes & lots
Quantity
Z-1832-2021
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06; Lot Number 54239375, exp. 02/01/2022
Verify the lot number and expiration date on the tray. The affected lot is 54368716, expiring June 1, 2022.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution to the states of MS, VA, LA, and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Louisiana, Mississippi, New York, Virginia.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1834-2021 (May 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1834-2021 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.