CLASS II Device recall · Reported 24 Nov 2021 · FDA Enforcement Report
Regard Stereotactic Tray recalled by ROi CPS
ROi CPS is recalling Regard Stereotactic Tray, distributed nationwide in the US. The recall was initiated on 10 Aug 2021 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-0254-2022
- FDA event ID
- 88463
- Recalling firm
- ROi CPS, Republic, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2021
- FDA classified
- 18 Nov 2021
- Reported
- 24 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2021 | Recall initiated by company | |
| 18 Nov 2021 | Classified by FDA | +100 days |
| 24 Nov 2021 | 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
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
REGARD Stereotactic Tray
Where it was distributed
US Nationwide in the states of FL, LA and MO.
Questions about this recall
Is Regard Stereotactic Tray recalled?
Yes. ROi CPS recalled Regard Stereotactic Tray on 10 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-0254-2022.
Why was it recalled?
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Which lots are affected?
Lots numbers: 81985C, 80891C and 80379C
Where was it sold?
US Nationwide in the states of FL, LA and 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 ROi CPS
All 86| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | regard Item Number: 830106006, LD01114F - Newborn Kit containing recalled | ROi CPS | Potency & Assay | MO |
| Device | CLASS II | regard Clinical Packaging Solutions, HT00376I - Special Procedure recalled | ROi CPS | Packaging Defects | Nationwide |
| Device | CLASS II | Regard Kit containing the Microtek decanter recalled by ROi CPS | ROi CPS | Sterility | Nationwide |
| Device | CLASS I | regard Operative LAP recalled by ROi CPS | ROi CPS | Other | LA |
| Device | CLASS I | Regard Dressing change kit recalled by ROi CPS | ROi CPS | Other | Nationwide |
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| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |