Medline C-Section Convenience Kits Recalled for Contaminated Components
Medline Industries is recalling 106 C-section convenience kits distributed nationwide due to potentially contaminated components.
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: The recall involves a medical device with a potentially contaminated component, representing a risk of harm where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.
Plain-English summary
Medline Industries, LP is recalling 106 C-section convenience kits labeled as C-SECTION (SKUs DYNJ904612L, DYNJ911755) and AHR C-SECTION KIT (SKU DYNJ912014). The recall was initiated because the kits contain a potentially contaminated component.
The affected products were distributed nationwide in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, and WI. Specific lot numbers and UDI/DI codes are available in the recall details.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 106
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 (12)
- Medline Kit SKU DYNJ904612L
- UDI/DI 10198459495625 (each) 40198459495626 (case)
- Lot Number 26FMC710
- Lot Number 26DMG417
- Medline Kit SKU DYNJ911755
- UDI/DI 10198459523946 (each) 40198459523947 (case)
- Lot Number 25KMI628
- Medline Kit SKU DYNJ912014
- UDI/DI 10198459599569 (each) 40198459599560 (case)
- Lot Number 26ABJ549
- Lot Number 26ABI899
- Lot Number 25LBT433.
Distribution
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