Device recalls

Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M

Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer

Open, ClassifiedProcess change controlZ-3023-2026
Open FDA's page for this record
Cfres ID
221702
Product res number
Z-3023-2026
Event date initiated
2026-07-10
Event date posted
2026-08-26
Recall status
Open, Classified
Res event number
99507
Product code
FTN
Product description
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Code info
UDI/DI 10198459447327 (each) 40198459447328 (case), kit lot number 25JBE079.
Firm FEI number
1417592
Recalling firm
Medline Industries, LP
Address 1
3 Lakes Dr
City
Northfield
State
IL
Postal code
60093-2753
Additional info contact
Haley Barclay 866359-633-5463
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause description
Process change control
Product quantity
15 kits
Distribution pattern
US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.
Action

Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-120-FG-FGX2 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Harmonized identifiers (openFDA)
Device name
Plastic Surgery And Accessories Kit
Medical specialty description
General, Plastic Surgery
Regulation number
878.3925
Device class
1
Registration number
3007279404, 3016659819, 1422634, 3004911384, 3004519921, 2431166, 2183650, 3039382823, 3004111573, 1030451, 1047429, 1423395, 2029015, 3004122598, 2084346, 3047515274, 3009964461, 3003431869, 1928237, 3015173212, 3005595283, 3005012805, 3045816907, 3009158523, 3015895045, 3007289408, 9680357, 3005032396, 3006389770, 3006231901, 9611024, 3035642068, 1720734, 3026197444, 3045816902, 2433012
FEI number
3007279404, 3016659819, 3004911384, 2183650, 1000514656, 3039382823, 3004111573, 1030451, 3000717925, 1047429, 3004122598, 3047515274, 3009964461, 3003431869, 1928237, 3015173212, 3005595283, 3005012805, 2523865, 1000160458, 3045816907, 3009158523, 3015895045, 3004829691, 3007289408, 3005032396, 1000124817, 3006389770, 3006231901, 3035642068, 3005846326, 1720734, 3002807170, 3026197444, 3045816902, 2433012
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.