Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ896…
Medline Industries, LP · Kits contain a potentially contaminated component which were recalled by the manufacturer
Open FDA's page for this record- Cfres ID
- 221701
- Product res number
- Z-3022-2026
- Event date initiated
- 2026-07-10
- Event date posted
- 2026-08-26
- Recall status
- Open, Classified
- Res event number
- 99507
- Product code
- FDE
- 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
- 94 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) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
- Code info
Medline Kit SKU CDS982040U, UDI/DI 10198459385421 (each) 40198459385422 (case), Lot Number 26AMC355; Medline Kit SKU DYNJ89608, UDI/DI 10198459279324 (each) 40198459279325 (case), Lot Number 25JBR465; Medline Kit SKU DYNJ903479L, UDI/DI 10198459255250 (each) 40198459255251 (case), Lot Number 25LMB480; Medline Kit SKU DYNJ903479M, UDI/DI 10198459790591 (each) 40198459790592 (case), Lot Number 26FMB173.
- 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
- Laparoscopy Kit
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- K number
- K942677, K950924, K955717, K912443
- Registration number
- 1060680, 3001675293, 3004911384, 2431166, 1043214, 3010041511, 3004111573, 9616088, 3014925393, 1030451, 9611102, 1047429, 1423395, 1418479, 2029015, 3004122598, 3011137372, 1423537, 3015612252, 1643817, 3016832577, 3010885402, 3015058854, 3007329020, 3011063460, 3004605321, 2320762, 1061124, 1928237, 3004362278, 3015173212, 3005595283, 3005012805, 3045816907, 3015895045, 3008513424, 1054241, 3007289408, 3003418325, 1055236 +7 more
- FEI number
- 3001675293, 3002902735, 3004911384, 3003040625, 3002808001, 1043214, 1000208624, 3010041511, 3004111573, 3014925393, 1030451, 3000717925, 1047429, 1418479, 3004122598, 3015612252, 1000112968, 1643817, 3016832577, 3010885402, 3015058854, 3007329020, 3011063460, 3004605321, 1928237, 3005747797, 3004362278, 3015173212, 3005595283, 3005012805, 1000112877, 2523865, 1000160458, 3045816907, 3015895045, 3008513424, 3007289408, 3003418325, 3014325891, 3013868968 +7 more