CLASS II Device recall · Reported 18 Jan 2023 · FDA Enforcement Report
DeRoyal Organ Recovery Pack Pgybk, a) recalled by DeRoyal Industries
DeRoyal Industries is recalling DeRoyal Organ Recovery Pack Pgybk, a), distributed nationwide in the US. The recall was initiated on 12 Dec 2022 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-0927-2023
- FDA event ID
- 91331
- Recalling firm
- DeRoyal Industries, Powell, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Dec 2022
- FDA classified
- 9 Jan 2023
- Reported
- 18 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 12 Dec 2022 | Recall initiated by company | |
| 9 Jan 2023 | Classified by FDA | +28 days |
| 18 Jan 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
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
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Where it was distributed
US Nationwide distribution in the states of IL, MO.
Questions about this recall
Is DeRoyal Organ Recovery Pack Pgybk, a) recalled?
Yes. DeRoyal Industries recalled DeRoyal Organ Recovery Pack Pgybk, a) on 12 Dec 2022. The recall is Class II and its status is Terminated. Recall number Z-0927-2023.
Why was it recalled?
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
Which lots are affected?
a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023
Where was it sold?
US Nationwide distribution in the states of IL, MO.
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 DeRoyal Industries
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|---|---|---|---|---|---|
| Device | CLASS II | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access recalled | DeRoyal Industries | Sterility | Nationwide |
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| Device | CLASS II | DeRoyal C-section Tracepack recalled by DeRoyal Industries | DeRoyal Industries | Other | Nationwide |
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