Medline medical procedure kits, containing Medline Neuro Sponges, labeled as fol...
Reason for Recall / Hazard
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 Description & Identification
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.
Affected Products
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98664 |
| Address 1 | 3 Lakes Dr |
| Code info | Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23JMB165; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23CMH103; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMH200; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMB495; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KMH108; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KME285; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23KMJ648; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 26BME013; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 2228 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260430 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.