Recall Z-2016-2026
Medline Industries, LP · initiated March 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.
Codes / lots: Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA668; Medline Kit Number/SKU CDS840402AI: UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA240; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25IMG470; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMI158; Medline Kit Number/SKU CDS984890V: UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMC404; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ILA647; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23HLA953; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23GLA064; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ELA715; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22KLB111; Medline Kit Number/SKU DYNJ0394874L: UDI/DI each…
Reason for recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
FDA-determined cause: Under Investigation by firm
Action taken
Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. 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. Distributors must notify their customers and should include customer 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Details
- Recall number
- Z-2016-2026
- Initiated
- March 19, 2026
- Posted by FDA
- April 30, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 4016 kits
- Distribution
- Worldwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2008-2026 Class II | Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2009-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2010-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2011-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2012-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2013-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2014-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2015-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2017-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2018-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2019-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2020-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2021-2026 Class II | Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2022-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2023-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2024-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2025-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2026-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2027-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total)…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2028-2026 Class II | Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2029-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2030-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2031-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2032-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2033-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2034-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2035-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2036-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2037-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |
| Z-2038-2026 Class II | Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total)…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… | 03/19/2026Open, Classified |