Medline surgical convenience kits recalled for weak seal integrity
Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard—potential sterility breach from weak seals in surgical kits—represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for severity score 3.
Plain-English summary
Medline Industries has recalled 7,673 non-sterile surgical convenience kits due to a component defect. The affected kits include Difficult Airway Trays, Adult/Child Intubation Kits, Intubation Trays, Anesthesia Trays, and Baby Care Kits that contain Pure Pouch components.
The Pure Pouch components in these kits have weak seals that may fail and breach the sterility of the contents. If a seal fails, the medical instruments inside may become contaminated, potentially compromising patient safety.
The recalled kits were distributed nationwide across Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming. Specific lot numbers and expiration dates are available from the FDA for identifying affected units.
Healthcare facilities and users who have these kits should discontinue use immediately. Anyone with questions or wishing to report adverse events should contact Medline Industries or the FDA.
The recalled product
- Product
- Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- seal-failure
- contamination-risk
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. Pack #ACC010578 - Lot number 24ADA089
- exp. 12/31/2024
- exp. 10/31/2024
- 23IDA980
- exp. 11/30/2024
- 23HDA517
- exp. 9/30/2024
- and 23DDB062
- exp. 4/30/2024. c. Pack #DYNJASA245A - Lot number 23JBT059
- exp. 4/30/2025
- exp. 8/31/2024
- exp. 3/31/2026
- 23LBD262
- 23IBN598
- exp. 7/31/2024
- 23GBF800
- 8/31/2025
- 23FBI255
- exp. 2/28/2025
- and 23CBT397
Distribution
Distributed nationwide across the United States.
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