Medline Nasal Pack Procedure Kits Recalled for Potential Endotoxin Contamination
Medline custom nasal pack procedure kits contain non-sterile surgical components with potential endotoxin contamination. Customers should discontinue use and contact Medline.
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 of surgical procedure kits containing non-sterile components with potential for endotoxin contamination. Although no illnesses or hospitalizations are reported in the source, non-sterile surgical materials represent a risk-of-harm product, meeting the High severity criterion.
Plain-English summary
Medline Industries is recalling custom medical procedure kits labeled as NASAL PACK, REF DYNJ67789A. The kits contain non-sterile Codman Surgical Patties and Surgical Strips, which have the potential for endotoxin contamination.
The recalled kits were distributed nationwide in the US and internationally in the UAE and Canada. A total of 80 units are included in this recall. Affected kits are identified by lot numbers 21GBW066, 21JBK474, 21KBS434, and 21KBX401.
Customers should immediately stop using these kits. Contact Medline Industries for instructions on returns or replacement of affected inventory.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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 (6)
- 1) REF DYNJ67789A
- UDI/DI 10193489945645 (EA) 40193489945646 (CS)
- Lot Numbers: 21GBW066
- 21JBK474
- 21KBS434
- 21KBX401
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
- ModerateMedline medical procedure kits recalled for endotoxin contamination
FDA (Devices) · 2026-05-06
- HighMedline surgical procedure kits recalled due to endotoxin contamination
FDA (Devices) · 2025-01-01
- HighMedline Surgical Patties and Strips Recalled for Out-of-Spec Endotoxin Contamination
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 Medical Procedure Kits with Neuro Sponges Recalled
FDA (Devices) · 2026-05-06