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-2024-2026
- 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
- Other Reasons
- Device type
- Surgical Instruments
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.
Product as listed by the FDA
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.
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 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.
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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