Medline brand — Class II medical device recall Z-0720-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-01, distributed nationwide. Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-th
| Recall number | Z-0720-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-11-06 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 6,467 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489201635, 10193489246995, 10193489283204, 10193489375947, 10193489750263, 10193489923384, 10195327092528, 10195327101312, 10195327102968, 10195327113506, 10195327156817, 10195327163402, 10195327211059, 10195327221355, 10195327224424, 10195327319038, 10195327322601, 10195327323745, 10195327326739, 10195327349103, 10195327384166, 10195327413019, 10195327452773, 10195327458416, 10195327459727 and 51 more |
| Lot numbers | 20FBM501, 20HBM389, 20IBH831, 20IMB575, 20JBO761, 20JBS998, 21ABO570, 21ABT938, 21FBC250, 21FMC923, 21GBO441, 21GMD178, 21HMF433, 21IBM868, 21JBJ197, 21JMB783, 22ABA377, 22CMC565, 22DMF954, 22EMG974, 22FBU440, 22GLA884, 22GMG160, 22HBH399, 22HLA029, 22HMF910, 22IDB976, 22JBJ632, 22JMB394, 22JMD852, 22KLA652, 22KMA630, 22KME394, 22LLA582, 22OBC118, 22OBC120, 23BBC727, 23BBQ143, 23BLA617, 23CME287 and 88 more |
Product
Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370
Reason for recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0720-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.