Class II Recall

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Nu

Summary

The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .

Details

Source

Device Recall

External ID

Z-2037-2026

Action Date

2026-05-06

Status

Ongoing

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.

Lot/Code Info: 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.

Quantity Affected: 3290 kits

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

Worldwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-19

Company

Medline Industries, LP

Northfield, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 275 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2037-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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