The Recall Desk
ModerateFDA (Devices)·Z-0665-2023·Announced 2022-12-21

DeRoyal Biopsy Pack Kits Subject to Voluntary Recall

DeRoyal Industries voluntarily recalled 360 kits of its BIOPSY PACK (Lot 57686568) distributed across 22 U.S. states. The specific reason for the recall is not specified in available FDA documentation.

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: FDA Class II medical device recall initiated voluntarily by the manufacturer. No specific hazard is documented in available FDA records, and the source material reports no illnesses or injuries.

Plain-English summary

DeRoyal Industries Inc initiated a voluntary recall of 360 kits of the DeRoyal BIOPSY PACK, Reference 89-9739.06, with Lot Number 57686568 (expiration 3/1/2027). The kits were distributed across 22 U.S. states including Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, and Georgia.

The recall was initiated on November 3, 2022, and classified as Class II by the FDA on December 15, 2022. The specific reason for the recall is not detailed in available FDA documentation.

Affected facilities should verify whether they have received products from Lot 57686568 and contact DeRoyal Industries Inc for instructions on handling the recalled items. The firm notified customers through email, fax, letter, press release, telephone, and direct contact.

The recalled product

Product
DeRoyal BIOPSY PACK, REF 89-9739.06
Manufacturer
DeRoyal Industries Inc
Category
Medical Device — Biopsy Equipment
Affected units
360

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 (1)

  • Lot Numbers: Lot 57686568 exp 3/1/2027

Distribution

Distributed in 23 states:

Part of a larger recall action

This product is one of 156 recalled by DeRoyal Industries 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 156 products in this recall →

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