The Recall Desk
HighFDA (Devices)·Z-0251-2022·Announced 2021-11-24

REGARD Core Biopsy Tray Recalled for Out-of-Specification Component

ROi CPS LLC recalled 1,200 REGARD Core Biopsy Trays distributed nationwide because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—an out-of-specification component—represents a potential risk rather than confirmed harm. Per the severity rubric, Class II recalls without hospitalization reports and with theoretical rather than realized risk score at 3 (High).

Plain-English summary

ROi CPS LLC is recalling the REGARD Core Biopsy Tray because a Povidone-Iodine swabstick component supplied by PDI, Inc. was manufactured out of specifications. This component is used in some of the affected biopsy trays. The FDA has classified this as a Class II recall.

Approximately 1,200 trays were distributed nationwide in Florida, Louisiana, and Missouri. The affected lot numbers are 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C, and 85427C.

Affected customers should stop using the identified lot numbers and contact ROi CPS LLC or the FDA for instructions on return or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
REGARD Core Biopsy Tray
Manufacturer
ROi CPS LLC
Category
Medical Device — Biopsy Equipment
Hazard
Affected units
1,200

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Lots numbers: 88004C
  • 87367C
  • 86986C
  • 83380C
  • 83062C
  • 82614C
  • 86178C and 85427C

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 7 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · ROi CPS LLC

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