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 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
