CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Medline medical procedure kits recalled by Medline Industries
Medline Industries is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2037-2026
- FDA event ID
- 98664
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 30 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 30 Apr 2026 | Classified by FDA | +42 days |
| 6 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 98664This product is part of a recall event; the main page for the event is Medline Neuro Sponges, various dimensions, labeled as recalled.
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