Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO...
FDA Device Recall #Z-2026-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-2026-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 9805 kits |
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L; 2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J; 3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I; 4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J; 5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B; 6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019; 7. ENT PACK, Medline Kit Number/SKU DYNJ86328; 8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263; 9. ENT PACK, Medline Kit Number/SKU DYNJ89675; 10. ENT PACK, Medline Kit Number/SKU DYNJ89675A; 11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493.
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.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25IMD003; Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25HMH643; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22GBS127; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22FBB472; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25FBE752; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25EBA260; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25DBG176; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25CBD819; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25BBA593; Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 24KBJ163; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23KMI415; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMK023; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMB211; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23IMC591; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23HMG291; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23GMG136; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23FME285; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23EME227; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23CMD903; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMI915; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMH419; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24JMG571; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24HMF066; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24FMG130; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24CMI441; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24BMD229; Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24AMH016; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26BMB944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26AMJ197; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25KMC587; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25JMD275; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25IMC944; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25GMF811; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25FME706; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25EMA516; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25CME296; Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 24LMD726; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 22HBH553; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 26BBF722; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25JBB835; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBO944; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBL998; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBH356; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBF751; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25DBB435; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25BBC547; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24KBR868; Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24JBV969; Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBB952; Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBC125; Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 22JBR211; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25LBS635; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25KBE004; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25HBR489; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25FBL484; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25DBD392; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25ABD635; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24KBB462; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24JBE518; Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24GBE890; Medline Kit Number/SKU DYNJ89263: UDI/DI each 10198459253348, UDI/DI case 40198459253349, Lot Number: 25BBK629; Medline Kit Number/SKU DYNJ89675: UDI/DI each 10198459281693, UDI/DI case 40198459281694, Lot Number: 25CME067; Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMG054; Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMA771; Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 25GME903; Medline Kit Number/SKU DYNJT7493: UDI/DI each 10198459626258, UDI/DI case 40198459626259, Lot Number: 26ABA254.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.