Medline Medical Procedure Kits Recalled Due to Non-Sterile Product Risk
Medline is recalling certain convenience kits for medical procedures due to potential non-sterile product risk if the breather pouch seal is compromised. The recall affects 51 units distributed in the US, Canada, and Panama.
What this means for you
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: This is an FDA Class II recall for a potential sterility hazard in medical procedure kits. The source text does not report any illnesses, injuries, or confirmed contamination. The hazard is theoretical—risk of non-sterile product if the pouch seal is compromised—making this a risk-of-harm product without reported injury.
Plain-English summary
Medline Industries is recalling certain medical procedure convenience kits because of a packaging defect that could result in non-sterile product exposure. The recalled kits were packaged in breather pouches with lot number 323080002. If the vendor seal on these pouches is opened or unsealed, there is potential for the product to become non-sterile.
The recall affects two product lines: NEURO PACK (REF DYNJ37909A, Lot 24ABG035) and SHUNT PACK (REF DYNJ40040C, Lot 23KBB863). A total of 51 units have been identified. These kits were distributed worldwide, including throughout the United States, Canada, and Panama.
Consumers, healthcare providers, and medical facilities who possess these kits should stop using them and contact Medline for instructions on return or replacement. The risk to patients exists if the pouch seal has been compromised and the product has been used.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK, REF DYNJ37909A; b) SHUNT PACK, REF DYNJ40040C
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical kit
- Affected units
- 51
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 (8)
- a) REF DYNJ37909A
- UDI/DI 40193489675451 (each)
- 10193489675450 (case)
- Lot Numbers: 24ABG035
- b) REF DYNJ40040C
- UDI/DI 40889942683971 (each)
- 10889942683970 (case)
- Lot Numbers: 23KBB863
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 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 33 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 · non sterile product
See all →- HighSaline nasal spray recalled over microbial contamination with Pseudomonas lactis
FDA (Drugs) · 2025-12-03
- SevereZicam cold remedy nasal swabs recalled over fungal contamination
FDA (Drugs) · 2025-07-09
- SevereOrajel Baby teething swabs recalled over fungal contamination of swabs
FDA (Drugs) · 2025-07-09
- SevereZicam Nasal AllClear swabs recalled over fungal contamination of swabs
FDA (Drugs) · 2025-07-09
- HighMedline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
FDA (Devices) · 2024-10-30