Class II Recall

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit N

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-2024-2026

Action Date

2026-05-06

Status

Ongoing

Product Description

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.

Lot/Code Info: Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 23DBM600; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22JBM081; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22ABJ346; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO873; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO877; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21JBX107; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBE213; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBB024; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 22AMD386; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21LMC822; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21JMF409; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21IMC184; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21GMB555; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21EMD626; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21CMC668; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21AMB081; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23FMD067; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23EMB306; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23CMD967; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22KMB384; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22OBB494; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22BBT747; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22ABA711; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21LBG900; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21KBD492; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21EBS624; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21CBY739; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21ABL492; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22KBD211; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBX995; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBL500; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 24CBB115; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB463; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB461; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBT464; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBP591; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23EBS895; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23CBU007; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23ABE854; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22LBE910; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22JBP701; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22FBV579; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ713; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ714; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21LBD683; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21IBM004; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21FBJ190; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21EBE932; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21DBA613; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21CBI323; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22FBM378; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22EBE987; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22OBI162; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21KBF463; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21IBU411; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21GBJ251; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21DBU812.

Quantity Affected: 2153 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-2024-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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