The Recall Desk
ModerateFDA (Devices)·Z-0802-2014·Announced 2014-01-29

Civco Belly Board Recalled Due to Misaligned Scales

Civco Medical Instruments is recalling 138 belly boards because scales may be misaligned from the zero reference, potentially affecting measurement accuracy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect involves a functional measurement error (misaligned scales) rather than a direct physical hazard like injury or contamination, fitting the criteria for moderate severity.

Plain-English summary

Civco Medical Instruments Inc is recalling 138 units of the Civco Belly Board, a reusable non-sterile carbon fiber belly board with cushion (REF 125012). The device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.

The recall is due to a defect where scales adhered to the product may be misaligned from the zero reference, causing one side to not match the other. This misalignment could affect the accuracy of the device's intended function.

The affected products were distributed worldwide, including nationwide in the United States and in various foreign countries. Consumers and healthcare facilities should stop using the affected belly boards and contact Civco Medical Instruments for further instructions.

The recalled product

Product
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Affected units
138

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 (20)

  • Lot #'s: M441670
  • M469970
  • M469980
  • M469990
  • M484910
  • M484920
  • M516200
  • M516210
  • M516220
  • M533340
  • M533350
  • M533360
  • M533370
  • M533380
  • M533970
  • M533980
  • M533990
  • M534000
  • M544650
  • M544660

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Civco Medical Instruments Inc 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 2 products in this recall →