Medline Deep Brain Stimulation Surgical Kits Recalled for Non-Sterile Contamination
Medline has recalled 128 Deep Brain Stimulation surgical kits for containing non-sterile Surgical Patties and Strips with potential endotoxin contamination. Affected units were distributed worldwide including the US, UAE, and Canada.
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 a risk-of-harm product where sterile surgical equipment has failed sterility controls and contains potential endotoxin contamination, which could cause serious patient harm if used in surgical procedures. No illnesses or injuries have been reported, placing this at the High severity level per the rubric.
Plain-English summary
Medline Industries, LP is recalling custom medical procedure kits labeled as Deep Brain Stimulation Pack-LF. The recall affects 128 units that contain Codman Surgical Patties and Surgical Strips.
These Surgical Patties and Strips are non-sterile and have the potential for endotoxin contamination. The items were intended to be sterile for use in surgical procedures, and the contamination poses a potential risk to patient safety.
The affected kits, identified by lot numbers 19BKB326, 19DKA892, 19JDA775, and 20ADC560, have been distributed worldwide including throughout the United States, United Arab Emirates, and Canada. Healthcare facilities should verify whether they have received these lot numbers and discontinue use if present.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 128
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 (5)
- UDI/DI 10889942825547 (EA) 40889942825548 (CS)
- Lot Numbers: 19BKB326
- 19DKA892
- 19JDA775
- 20ADC560
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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