Recall Z-2037-2026
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. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.
Codes / lots: Medline Kit Number/SKU DYNJ48725A: UDI/DI each 10193489853896, UDI/DI case 40193489853897, Lot Number: 24IMG757; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22FME241; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22DMC340; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21JMC829; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21IMC497; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21HMD139; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21GME747; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21FMA440; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21DBU602; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21CBJ936; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554…
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-2037-2026
- Initiated
- March 19, 2026
- Posted by FDA
- April 30, 2026
- Product code
- OJK – Eye Tray
- Quantity
- 3290 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-2016-2026 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-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 |