DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration
DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which requires a minimum severity score of 4. Although no deaths or serious injuries have been reported, the Class I designation reflects the serious nature of medication mislabeling in surgical products.
Plain-English summary
DeRoyal Industries Inc is recalling certain lots of surgical procedure packs (DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06, Lot Number 54239375, expiration 02/01/2022, quantity 12 trays). The packs are mislabeled: they contain 0.5% Bupivacaine but are labeled as containing Hospira Pfizer 1% Lidocaine.
The discrepancy between the actual product and the label creates a medication identification hazard in the surgical setting.
The affected products were distributed nationwide to healthcare facilities in Mississippi, Virginia, Louisiana, and New York. Customers with these products should discontinue use and contact DeRoyal Industries Inc.
The recalled product
- Product
- DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
- Manufacturer
- DeRoyal Industries Inc
- Hazard
- medication-mislabeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 54239375
- exp. 02/01/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03