Medline Tubal Ligation Kits Recalled for Adhesive Removal Issues
Medline Industries is recalling three tubal ligation kits because they are difficult to remove from patients and leave adhesive residue on the skin.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source describes the hazard as the product being difficult to remove and leaving adhesive residue on the skin. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling three MEDLINE medical convenience kits labeled as TUBAL LIGATION RFD, Product Number/SKU DYNJ906291G. The recall involves Lot number 26GBQ124. The kits were distributed worldwide, including the United States, Canada, Turkey, Australia, and the United Arab Emirates.
The recall was initiated due to reports that the product is difficult to remove from patients and leaves adhesive residue on the patient's skin. The source text does not report any illnesses, injuries, or deaths associated with this issue.
Healthcare providers and consumers should stop using the affected kits. Medline Industries is the firm responsible for the recall.
The recalled product
- Product
- MEDLINE medical convenience kits labeled as: TUBAL LIGATION RFD, Medline Product Number/SKU DYNJ906291G
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Affected units
- 3
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 (2)
- UDI/DI 10198459847752 (each) 40198459847753 (case)
- Lot numbers: 26GBQ124
Distribution
Distributed nationwide across the United States.
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