Medline procedural kits recalled for plastic syringe defects
Medline is recalling procedural kits containing plastic syringes with leaks, breakage, and other quality defects. These defects may pose a risk to patient safety.
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 medical device recall of surgical kits with identified quality defects (leaks, breakage) that may pose risk to patient safety. No illnesses or injuries reported in the source, limiting the score to 3 per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries is recalling procedural kits containing plastic syringes affected by quality defects including leaks, breakage, and other issues. The recalled kits are distributed worldwide and are identified by specific pack numbers and lot numbers provided by the FDA.
These defects in the plastic syringes may pose a risk to patient health. Healthcare facilities that have received affected kits should identify potentially affected products using the pack and lot numbers identified in the FDA recall notice.
Facilities with affected kits should immediately discontinue use of the identified lot numbers. Healthcare providers should contact Medline Industries or the FDA with any questions regarding the recall or if they have concerns about syringes already received or used.
The recalled product
- Product
- Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
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)
- DYNJ51654A
- Lot Number:23HBZ446
- DYNJ0855117O
- Lot Number:23GME420
- Lot Number:23IMA529
- Lot Number:24AMG373
- DYNJ53847D
- Lot Number:23AMJ016
- Lot Number:23EMJ451
- Lot Number:23FMF604
- Lot Number:23JMI394
- Lot Number:23KMB963
- Lot Number:24AMA722
- DYNJ83699A
- Lot Number:24CMG922
- DYNJ81805
- Lot Number:23FMD167
- Lot Number:23GMA680
- Lot Number:23JMD040
- Lot Number:24AMA541
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 27 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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