CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Centurion-Surgical trays DYNJ04079Z Circumcision Tray recalled

Centurion Medical Products is recalling Centurion-Surgical trays DYNJ04079Z Circumcision Tray Sterile DYNJ08835 Debridement Tray, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: DYNJ04079Z CIRCUMCISION TRAY STERILE 2019010790 DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL 2018111390 DYNJ1000 NEWBORN CIRCUMCISION TRAY 2019021890
Quantity recalledN/A

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-1064-2020
FDA event ID
84530
Recalling firm
Centurion Medical Products, Williamston, MI
Classification
Class II
Status
Terminated
Recall initiated
11 Dec 2019
FDA classified
5 Feb 2020
Reported
12 Feb 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

11 Dec 2019Recall initiated by company
5 Feb 2020Classified by FDA+56 days
12 Feb 2020Published in enforcement report+7 days

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

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY

Where it was distributed

Nationwide Foreign: GHANA

Nationwide

Questions about this recall

Is Centurion-Surgical trays DYNJ04079Z Circumcision Tray Sterile DYNJ08835 Debridement Tray recalled?

Yes. Centurion Medical Products recalled Centurion-Surgical trays DYNJ04079Z Circumcision Tray Sterile DYNJ08835 Debridement Tray on 11 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1064-2020.

Why was it recalled?

Incomplete seals on the sterile package may compromise the sterility

Which lots are affected?

Lot Numbers: DYNJ04079Z CIRCUMCISION TRAY STERILE 2019010790 DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL 2018111390 DYNJ1000 NEWBORN CIRCUMCISION TRAY 2019021890

Where was it sold?

Nationwide Foreign: GHANA

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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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