Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARA...
FDA Device Recall #Z-2037-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-2037-2026 |
| 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 | 3290 kits |
Product Description
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.
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 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, UDI/DI case 40195327112555, Lot Number: 23IBC227; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23FBA458; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23DBC239; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23ABI841; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBP260; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBO842; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBN801; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22GBL794; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24HBB998; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24DBQ664; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24CBQ260; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 26ABC645; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25LBB014; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25JBM975; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25HBN493; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25GBM010; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25FBJ206; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25CBN002; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABF979; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABA086; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBE583; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBG667; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25KBQ749; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25JBF743; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25IBA573; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBO985; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBB916; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24GBY148; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24EBO714; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 23LBH320; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBO017; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23JBA275; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23GBK387; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23CBD302; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 26ABF562; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25GBF664; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25EBB838; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25BBQ021; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24LBB454; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24JBE139; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24GBI010; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24FBR965; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24DBQ797; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24BBH448; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23LBL498; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBX879; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23IBE948; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23FBB413; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABN367; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABA089; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23KBU302; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25LBL874; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25HBD880; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25EBI919; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBG184; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBF578; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24JBS764; Medline Kit Number/SKU DYNJ89030: UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25JBH439; Medline Kit Number/SKU DYNJ89030: UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25ABP922; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBW005; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBG214; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBP153; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBN621; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBW204; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBE141; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24DBP594; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB058; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB100; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23LBE522; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMB048; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMA495; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 22LMD749; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMI877; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMH413; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25GMJ496; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25DMD357; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25AMJ130; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24IME711; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24HME507; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24DMF364; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMI687; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMG984; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24BMI425.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2234-2026 | 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-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2233-2026 | 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.