CLASS I Device recall · Reported 16 Jun 2021 · FDA Enforcement Report

DeRoyal Pacemaker Tray Pgybk recalled by DeRoyal Industries

DeRoyal Industries is recalling DeRoyal Pacemaker Tray Pgybk, distributed nationwide in the US. The recall was initiated on 14 May 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Number 54239375, exp. 02/01/2022
Quantity recalled12 trays

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1832-2021
FDA event ID
87949
Recalling firm
DeRoyal Industries, Powell, TN
Classification
Class I
Status
Terminated
Recall initiated
14 May 2021
FDA classified
10 Jun 2021
Reported
16 Jun 2021
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Labeling Errors

Timeline

14 May 2021Recall initiated by company
10 Jun 2021Classified by FDA+27 days
16 Jun 2021Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06

Where it was distributed

US Nationwide distribution to the states of MS, VA, LA, and NY.

Nationwide LouisianaMississippiNew YorkVirginia

Questions about this recall

Is DeRoyal Pacemaker Tray Pgybk recalled?

Yes. DeRoyal Industries recalled DeRoyal Pacemaker Tray Pgybk on 14 May 2021. The recall is Class I and its status is Terminated. Recall number Z-1832-2021.

Why was it recalled?

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

Which lots are affected?

Lot Number 54239375, exp. 02/01/2022

Where was it sold?

US Nationwide distribution to the states of MS, VA, LA, and NY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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