Device recalls

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ9…

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

Open, ClassifiedProcess change controlZ-3028-2026
Open FDA's page for this record
Cfres ID
221707
Product res number
Z-3028-2026
Event date initiated
2026-07-10
Event date posted
2026-08-26
Recall status
Open, Classified
Res event number
99507
Product code
OKV
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
419 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.
Product description

Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.

Code info

Medline Kit SKU DYNJ54362F, UDI/DI 10198459794292 (each) 40198459794293 (case), Lot Number 26EMF986; Medline Kit SKU DYNJ900957C, UDI/DI 10195327599461 (each) 40195327599462 (case), Lot Number 25IBP434; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 26BBA665; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25KBR602; Medline Kit SKU DYNJ906804B, UDI/DI 10195327433376 (each) 40195327433377 (case), Lot Number 25JBH531; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25KBL876; Medline Kit SKU DYNJ910195A, UDI/DI 10198459556838 (each) 40198459556839 (case), Lot Number 25JBS218.

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
Obstetrical Kit
Medical specialty description
Obstetrics/Gynecology
Regulation number
884.4520
Device class
2
Registration number
3045816907, 1928237, 3006410968, 1721432, 3045816902, 1030451, 1423537, 1047429, 3011144486, 3009337401, 2029015, 3009888344, 3007329020, 3005012805, 3005595283, 2433012, 1123137, 9616088, 3004122598, 3010155661, 3035642068, 1643817, 3015173212, 1423395, 3002807314, 1061124, 3004111573
FEI number
3045816907, 3001236905, 1928237, 3006410968, 1721432, 3045816902, 1030451, 1047429, 3011144486, 3009337401, 3002902735, 3009888344, 3007329020, 1000160458, 3005012805, 3005595283, 2433012, 3000717925, 3004122598, 3010155661, 3035642068, 1643817, 1000512168, 1000123180, 3015173212, 3002807314, 3004111573
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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.