Medline Procedure Kits Recalled for Non-Sterile Product Risk
Medline medical procedure kits may contain non-sterile product if the breather pouch seal is opened or compromised. The recall affects 320 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 a Class II medical device recall for sterile medical procedure kits. The hazard—potential non-sterile product due to seal failure—poses a risk of harm if used in medical procedures. No illnesses or injuries have been reported, making this a risk-of-harm product without reported injury.
Plain-English summary
Medline Industries is recalling Medline brand medical procedure convenience kits, including the PAIN PROCEDURE PACK (REF DYNJ80370A) and DR HEFZY BLOCK TRAY (REF DYNJRA1854A). These sterile kits are used in medical procedures such as pain blocks.
Kits in breather pouch lot 323080002 may contain non-sterile product if the vendor seal is opened or unsealed. This compromises the sterile packaging that is essential for safe use in medical procedures.
The affected 320 units were distributed worldwide, including the United States, Canada, and Panama. Healthcare providers and facilities that received these products should verify lot numbers and immediately remove affected units from service.
If you have received any of these kits with lot number 323080002, do not use them. Contact Medline Industries or follow your healthcare facility's recall procedures for proper handling and return.
The recalled product
- Product
- Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- seal-failure
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) DYNJ80370A
- UDI/DI 40195327388547 (each)
- 10195327388546 (case)
- Lot Numbers: 23LBM330
- b) DYNJRA1854A
- UDI/DI 40195327117062 (each)
- 10195327117061 (case)
- Lot Numbers: 23LBJ089
Distribution
Distributed nationwide across the United States.
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