Surgical convenience kits recalled for sterile barrier defect
Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.
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 involving a structural packaging defect that compromises the sterile barrier of a medical device kit. No illnesses or injuries have been reported, making this a risk-of-harm situation where the theoretical hazard of contamination has not yet resulted in documented harm.
Plain-English summary
Medline Industries, LP is recalling 1537 Surgical Convenience Kits labeled MEDLINE LCPH LAB DRAW KIT (Reorder Number DYNDH1641A, Lot 22HMH339) distributed nationwide. These kits are designed to provide sterile contents for medical procedures and lab work.
The outer bag has a perforation that prevents the exterior wrapping from being sterile. While the contents inside the kit wrapping remain sterile, the non-sterile outer surface creates a potential contamination pathway.
This defect compromises the integrity of the sterile barrier that the kit is designed to provide during handling, storage, and use. Healthcare providers should be aware that the external surface cannot be relied upon as a sterile barrier.
The recalled product
- Product
- Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 1,537
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 (3)
- Reorder Number DYNDH1641A
- GTIN 40195327005830
- Lot # 22HMH339
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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 20 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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- ModerateMedline Convenience Kits sterilization calibration issue recalled
FDA (Devices) · 2026-05-13
- SevereMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- HighMedline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02
- HighMedline Medical Procedure Convenience Kits Recalled for Sterility Risk
FDA (Devices) · 2024-10-30
- HighMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02