Medline Breast Biopsy Kits Recalled for Syringe Quality Issues
Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.
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: This recall is classified as FDA Class II and involves a risk-of-harm medical device (defective syringes in surgical kits). While no illnesses or injuries have been reported, the identified defects pose a theoretical risk to patient health during medical procedures.
Plain-English summary
Medline Industries is recalling multiple breast biopsy convenience kits containing plastic syringes. The affected kits are labeled as NHP Breast Biopsy Pack, Breast Biopsy Tray, and Breast Biopsy Pack, with multiple lot numbers identified in the recall.
The plastic syringes in these kits are subject to an FDA Safety Alert issued on March 19, 2024. Identified defects include leaks, breakage, and other quality issues that may pose a risk to patient health.
These convenience kits have been distributed worldwide.
The recalled product
- Product
- Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
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)
- DYNJ17400B
- Lot Number 23ABV075
- Lot Number 23ABV141
- Lot Number 22KBA557
- Lot Number 22GBJ307
- Lot Number 22DBU457
- DYNJ32049A
- Lot Number 19AKB211
- Lot Number 19CKA247
- DYNJ44987G
- Lot Number 21FBJ607
- Lot Number 21IBE237
- Lot Number 21KBA883
- Lot Number 21LBO984
- Lot Number 22CBN087
- Lot Number 20BBQ959
- Lot Number 20FBI170
- Lot Number 20JBL731
- Lot Number 21ABF141
- Lot Number 21CBF976
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 81 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.
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