Medline Leg Bags Recalled Due to Undeclared Latex
Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.
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: This is an FDA Class II recall for undeclared latex allergen on a medical device. Allergen mislabeling on common allergens meets the High (3) severity criteria per the rubric.
Plain-English summary
Medline Industries, LP is recalling approximately 19,406 Medline Leg bags (REF DYND12578) distributed in the United States and Panama. The recall was initiated on October 19, 2023, and is ongoing.
The leg bags contain undeclared latex, which poses an allergic reaction hazard to patients with latex sensitivity. The affected lot numbers are 48623040001, 48623050001, 48623060001, 48623070001, and 48623080001, identified by UDI/DI 40080196990321 (case) and 10080196990320 (insert).
Patients currently using this device should discontinue use and contact their healthcare provider for a replacement. Healthcare providers should verify latex allergy status in affected patients and counsel them on appropriate alternative products.
The recalled product
- Product
- Medline Leg bag, REF DYND12578
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 19,406
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 (7)
- UDI/DI 40080196990321 (case)
- 10080196990320 (insert)
- Lot Numbers: 48623040001
- 48623050001
- 48623060001
- 48623070001
- 48623080001
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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