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
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
- Device type
- Surgical Instruments
Timeline
| 11 Dec 2019 | Recall initiated by company | |
| 5 Feb 2020 | Classified by FDA | +56 days |
| 12 Feb 2020 | Published 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
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.
More recalls from Centurion Medical Products
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|---|---|---|---|---|---|
| Device | CLASS II | Centurion Difficult IV KIT containing BD's Vacutainer recalled | Centurion Medical Products | Foreign Material | Nationwide |
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| Device | CLASS II | Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled | Centurion Medical Products | Sterility | Nationwide |
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Other Surgical Instruments recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |