CLASS II ONGOING Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
Fabco Ors Dental Rolls, 1-1/2" Sterile recalled by Carwild
Carwild is recalling Fabco Ors Dental Rolls, 1-1/2" Sterile, Cotton 3/8" Diameter x 1-1/2" x, packaged 5, distributed nationwide in the US. The recall was initiated on 2 Aug 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-1747-2022
- FDA event ID
- 90808
- Recalling firm
- Carwild, New London, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Aug 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 2 Aug 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +44 days |
| 21 Sep 2022 | Published 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
Sterility with new cotton source not validated
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
FABCO ORS DENTAL ROLLS, 1-1/2" STERILE, COTTON 3/8" Diameter x 1-1/2" (9.5mm x 38.1mm), packaged 5 /Pouch, 50 Pouches/Box Reorder Number: 34911510
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Sterility with new cotton source not validated
Which lots are affected?
UDI-DI: Unit of Use: 00634303020740 Primary: 30634303020741 Lot Number: 22B0428
Where was it sold?
US Nationwide
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 26 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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|---|---|---|---|---|---|
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