The Recall Desk
HighFDA (Devices)·Z-0254-2022·Announced 2021-11-24

Out-of-Specification Swabstick Recalled in REGARD Stereotactic Tray

ROi CPS LLC recalled REGARD Stereotactic Trays due to out-of-specification Povidone-Iodine swabstick components. The recall affects 175 units distributed in Florida, Louisiana, and Missouri.

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: FDA Class II medical device where a component failed to meet specifications. No illnesses or injuries reported. Stereotactic trays are used in high-risk neurosurgical procedures, warranting scrutiny of quality issues.

Plain-English summary

ROi CPS LLC is recalling 175 units of the REGARD Stereotactic Tray due to a Povidone-Iodine swabstick component manufactured by PDI, Inc. that was found to be out of specifications.

The affected trays were distributed nationwide in Florida, Louisiana, and Missouri, with lot numbers 81985C, 80891C, and 80379C. The specific nature of the specification failure has not been disclosed.

No illnesses or injuries have been reported. Individuals with access to affected devices should contact ROi CPS LLC for further information.

The recalled product

Product
REGARD Stereotactic Tray
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Equipment
Hazard
  • product-defect

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 (2)

  • Lots numbers: 81985C
  • 80891C and 80379C

Distribution

Distributed nationwide across the United States.

Related recalls

Same category