Medical device recall for DeRoyal TRANS CANAL PACK units
DeRoyal Industries Inc is voluntarily recalling 156 kits of the TRANS CANAL PACK medical device distributed across 23 U.S. states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II voluntary recall initiated by the firm with no reported illnesses, injuries, or fatalities. The specific hazard is not stated in the source material. Voluntary precautionary recalls without documented harm are classified as Moderate per the rubric.
Plain-English summary
DeRoyal Industries Inc is voluntarily recalling 156 kits of the DeRoyal TRANS CANAL PACK (Reference 89-7157.12), a medical device classified as Class II by the FDA.
The specific reason for this recall is not stated in the available source material. The affected lots are: Lot 57029630 (expiration 8/1/2024), Lot 57387111 (expiration 6/1/2026), and Lot 57894800 (expiration date not specified).
The recalled units were distributed across 23 U.S. states: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, and Mississippi. The recall was initiated on November 3, 2022, and remains ongoing.
Consumers and healthcare facilities with possession of affected units should contact DeRoyal Industries Inc for further instructions regarding the recall.
The recalled product
- Product
- DeRoyal TRANS CANAL PACK, REF 89-7157.12
- Manufacturer
- DeRoyal Industries Inc
- Category
- Medical Device
- Affected units
- 156
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 (3)
- Lot Numbers: Lot 57029630 exp 8/1/2024
- Lot 57387111 exp 6/1/2026
- Lot 57894800 exp ***
Distribution
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 →Related recalls
Same manufacturer · DeRoyal Industries Inc
See all →- ModerateDeRoyal Myocardial Probe Recall Due to Incorrect Needle Length
FDA (Devices) · 2026-09-30
- ModerateVascular Access Dressing Recalled Due to Lack of Sterility Assurance
FDA (Devices) · 2026-06-10
- HighDeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues
FDA (Devices) · 2025-03-12
- HighDeRoyal AMG Suction Connector Tubing connection may fail to seal
FDA (Devices) · 2025-02-26
- HighDeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled
FDA (Devices) · 2024-11-13
Similar recalls
- ModerateDeRoyal Sterile Custom Kits Recalled for Defective Connectors
FDA (Devices) · 2022-09-07
- ModerateDeRoyal Heart Tracecart Recall Due to Contained Chest Drainage Product Issue
FDA (Devices) · 2017-03-01
- HighDeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals
FDA (Devices) · 2023-07-12
- HighDeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal
FDA (Devices) · 2014-10-29
- ModerateDeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
FDA (Devices) · 2014-08-06
- HighDeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility
FDA (Devices) · 2013-09-04