Medline Convenience Kits for Obstetrical Procedures Recalled for Weak Seals
Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.
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: FDA Class II recall of sterile medical device kits with a manufacturing defect (weak packaging seals) that could compromise product sterility and introduce contamination risk. The source text indicates no reported illnesses or injuries, but the defect poses a meaningful risk to patient safety in high-risk obstetrical contexts.
Plain-English summary
Medline Industries, LP (Northfield) is recalling 21,935 units of Medline Convenience kits used for obstetrical procedures, including labor and delivery packs and vaginal delivery packs. The recall affects 55 different product models and lot numbers.
The kits are being recalled due to a potential for open or weak seals on purchased breather pouches used for packaging the sterile products. Weak or compromised seals on the packaging could affect product sterility.
The affected products were distributed worldwide, including to the US, Canada, Mexico, Panama, and the Virgin Islands. Hospitals and healthcare facilities that received these kits should verify their inventory against the specific model numbers and lot numbers listed in this recall and take appropriate action to quarantine and return affected products to Medline Industries.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-compromise
- 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)
- 1) DYNJ26971L
- UDI-DI: 10198459087158(each)
- 40198459087159(case)
- Lot Number: 24IBD872
- 2) DYNJ0378319P
- UDI-DI: 10198459105722(each)
- 40198459105723(case)
- Lot Number: 24IBF374
- 3) DYNJ64017B
- UDI-DI: 10195327550325(each)
- 40195327550326(case)
- Lot Number: 24IBG070
- 4) DYNJHTLD04A
- UDI-DI: 10193489303346(each)
- 40193489303347(case)
- Lot Number: 24IBH288
- 5) HM190A
- UDI-DI: 10195327305161(each)
- 40195327305162(case)
- Lot Number: 24IBH818
Distribution
Distributed nationwide across the United States.
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