Medline custom surgical procedure kits recalled for non-sterile components
Medline is recalling 182 custom surgical procedure kits containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. The kits were distributed in the US, UAE, and Canada.
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: The recall involves non-sterile surgical supplies with potential endotoxin contamination—a risk-of-harm situation in an invasive procedure context. No illnesses or injuries have been reported. Although classified as FDA Class II, the absence of reported hospitalizations places this below the Severe threshold, but the serious contamination risk justifies High severity.
Plain-English summary
Medline Industries is recalling 182 custom medical procedure kits designed for cervical spine surgery. The affected products are labeled as CERVICAL PACK-LF (REF DYNJ0867145G), CERVICAL SPINE PACK HUM-LF (REF DYNJ35184F), and ANTERIOR CERVICAL-CORPECTOMY (REF DYNJ904827).
The kits are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips that have the potential for endotoxin contamination.
The affected kits were distributed worldwide, including throughout the United States, the United Arab Emirates, and Canada.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 182
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 (15)
- 1) REF DYNJ0867145G
- UDI/DI 10889942625413 (EA) 40889942625414 (CS)
- Lot Numbers: 19BDA435
- 19DDD135
- 2) REF DYNJ35184F
- UDI/DI 10889942567737 (EA) 40889942567738 (CS)
- Lot Numbers: 19CBC965
- 19QBC217
- 3) REF DYNJ904827
- UDI/DI 10889942743742 (EA) 40889942743743 (CS)
- Lot Numbers: 19DBD844
- 19HBO089
- 19HBQ573
- 19IBQ930
- 19SBE329.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 18 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
FDA (Devices) · 2025-01-01
- HighSurgical procedure kits recalled for elevated endotoxin levels
FDA (Devices) · 2025-01-01
- HighMedline Surgical Patties and Strips Recalled for Endotoxin Contamination
FDA (Devices) · 2025-01-01
- HighMedline medical procedure kits with neuro sponges recalled for endotoxin
FDA (Devices) · 2026-05-06
- HighMedline Neuro Sponges in Spine Procedure Kits Recalled for Out-of-Specification Endotoxin
FDA (Devices) · 2026-05-06
- ModerateMedline Neuro Sponges Cervical Pack Kits Recalled for Endotoxin
FDA (Devices) · 2026-05-06