Medline Hysteroscopy and Sling Packs subject to regulatory rescission
FDA has rescinded 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in two Medline medical device kits distributed nationwide.
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 indicates FDA Class II classification. The recall involves regulatory rescission of clearances rather than reported safety failures, illness, or injury, making it a precautionary regulatory action without evidence of actual harm.
Plain-English summary
Medline Industries, LP is recalling two medical device kits: the Hysteroscopy Pack (Model DYNJ48399C, Lot 24CBU779) and the Sling Pack (Model DYNJ62849B, Lot 24BBS275). A total of 89 units were distributed nationwide.
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components included in these kits. This action means the devices no longer have valid premarket clearance for use.
Patients or healthcare providers who have received or are using these kits should contact Medline Industries, LP for further instructions regarding the affected products.
The recalled product
- Product
- Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
- Manufacturer
- Medline Industries, LP
- Affected units
- 89
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 (8)
- 1) DYNJ48399C
- UDI-DI: 10195327172626(each)
- 40195327172627(case)
- Lot Number: 24CBU779
- 2) DYNJ62849B
- UDI-DI: 10195327514884(each)
- 40195327514885(case)
- Lot Number: 24BBS275
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Medline Industries, LP 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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