CLASS II Device recall · Reported 9 Dec 2020 · FDA Enforcement Report
Regard - Product Usage: Obstetric Gynecologic specialized manual recalled
ROi CPS is recalling Regard - Product Usage: Obstetric Gynecologic specialized manual, distributed nationwide in the US. The recall was initiated on 12 Oct 2020 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-0524-2021
- FDA event ID
- 86626
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2020
- FDA classified
- 2 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 12 Oct 2020 | Recall initiated by company | |
| 2 Dec 2020 | Classified by FDA | +51 days |
| 9 Dec 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
Labeling error, incorrect expiration date.
Product as listed by the FDA
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Where it was distributed
US Nationwide distribution in the states of MO and OK.
Questions about this recall
Is Regard - Product Usage: Obstetric Gynecologic specialized manual recalled?
Yes. ROi CPS recalled Regard - Product Usage: Obstetric Gynecologic specialized manual on 12 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0524-2021.
Why was it recalled?
Labeling error, incorrect expiration date.
Which lots are affected?
Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C.
Where was it sold?
US Nationwide distribution in the states of MO and OK.
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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