DeRoyal TLIF Procedure Packs Recalled Due to Included 3M Steri Drapes
DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple 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 3/5 (High).
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 recall with no reported illnesses or injuries. The recall involves a risk-of-harm product—surgical procedure packs containing separately recalled components—where injury has not yet been reported.
Plain-English summary
DeRoyal Industries Inc is recalling DeRoyal TLIF PACK (REF 89-8780.04) procedure packs that contain 3M Health Care Steri Drapes, which have been separately recalled by 3M. A total of 64 kits are affected.
The recalled procedure packs were distributed across the United 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, Georgia, and Mississippi.
The affected lot numbers are Lot 56020431 (expiration 9/1/2023) and Lot 56390757 (expiration 1/1/2024). Healthcare facilities and surgical centers that received these procedure packs should immediately stop using them and contact DeRoyal Industries Inc for instructions on return or replacement.
The recalled product
- Product
- DeRoyal TLIF PACK, REF 89-8780.04
- Manufacturer
- DeRoyal Industries Inc
- Affected units
- 64
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)
- Lot Numbers: Lot 56020431 exp 9/1/2023
- Lot 56390757 exp 1/1/2024
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 Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall
FDA (Devices) · 2024-11-13
Similar recalls
- HighDeRoyal Recalls Sterile Surgical Kits Due to Sterilant Exposure
FDA (Devices) · 2015-11-18
- HighDeRoyal Surgical Kits Recalled Due to Sterilant Exposure
FDA (Devices) · 2015-11-18
- HighMedical Procedure Packs with Compromised Package Seals Recalled
FDA (Devices) · 2023-07-12
- HighCustom Medical Procedure Packs Recalled for Compromised Package Seals
FDA (Devices) · 2023-07-12
- HighDeRoyal Pelvic Exam Trays Recalled Due to Compromised Package Seals
FDA (Devices) · 2023-07-12
- Severe3M Steri-Drape Surgical Drapes Recalled for Adhesive-Related Skin Injuries
FDA (Devices) · 2022-11-30