Medline Medical Procedure Kits Recalled for Potential Sterility Compromise
Medline is recalling specific medical procedure convenience kits because a packaging defect could allow non-sterile product to be used if the vendor seal is opened.
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 a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Medline Industries, LP is recalling 2,426 units of Medline brand medical procedure convenience kits. The affected products include various biopsy packs, trays, and kits, such as the Cone Biopsy Pack, Biopsy Tray, and CT Biopsy kit. These products were distributed nationwide in the United States, as well as in Canada and Panama.
The recall was initiated because certain convenience kits were packaged in breather pouches with lot number 323080002. It has been determined that if the vendor seal of these specific pouches is opened or unsealed, there is a potential risk that the product inside may be non-sterile. The source text does not report any illnesses or injuries associated with this defect.
Healthcare facilities and consumers should check their inventory for the specific reference numbers and lot numbers listed in the recall notice. If the products are found, they should be removed from use and returned to Medline Industries, LP for credit or replacement according to the company's instructions.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) CONE BIOPSY PACK, REF DYNJ17534L; b) BIOPSY TRAY, REF DYNJ43076A; c) LOU LOOP RECORDER PACK, REF DYNJ49404C; d) CT BIOPSY, REF DYNJ52666C; e) BIOPSY KIT, REF DYNJ61130B; f) ASPEN SOFT TISSUE PACK, REF…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 2,426
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 (20)
- a) REF DYNJ17534L
- UDI/DI 40195327258253 (each)
- 10195327258252 (case)
- Lot Numbers: 23KBF936
- b) REF DYNJ43076A
- UDI/DI 40195327080625 (each)
- 10195327080624 (case)
- Lot Numbers: 23LBI584
- c) REF DYNJ49404C
- UDI/DI 40195327395453 (each)
- 10195327395452 (case)
- Lot Numbers: 23LBP833
- d) REF DYNJ52666C
- UDI/DI 40193489452144 (each)
- 10193489452143 (case)
- Lot Numbers: 23LBN740
- e) REF DYNJ61130B
- UDI/DI 40195327054589 (each)
- 10195327054588 (case)
- Lot Numbers: 23LBP401
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 · 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
- HighMedline sterile convenience kits recalled for potential weak breather pouch seals
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- HighMedline surgical convenience kits recalled due to defective plastic syringes
FDA (Devices) · 2024-09-18
- HighMedline Medical Convenience Kits Recalled Due to Syringe Quality Issues
FDA (Devices) · 2024-09-18
- HighMedline Sterile Procedure Kits recalled for potential seal issues
FDA (Devices) · 2025-04-23
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09