Medline Kits containing Codman Disposable Perforator 14 mm: 1 — Class I medical device recall Z-1811-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-06-11, distributed in CA, FL, IL, IN, KY, MA, MD, MN…. Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on s
| Recall number | Z-1811-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-04-22 |
| Classified | 2025-05-30 |
| Reported by FDA | 2025-06-11 |
| Distributed | CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA, WI |
| Quantity | 1,853 total |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10195327144760, 10195327201579, 10195327395728, 10195327403270, 10195327410506, 10195327457945, 10195327466466, 10195327506872, 10195327510831, 10195327512996, 10195327531218, 10195327554323, 10195327574055, 10195327645090, 10198459009785, 10198459058172, 10888277771512, 40195327144761, 40195327201570, 40195327395729, 40195327403271, 40195327410507, 40195327457946, 40195327466467, 40195327506873 and 9 more |
| Lot numbers | 23IBO314, 23IDB680, 23JBC218, 23JBI747, 23JBK426, 23JDB683, 23JDC548, 23JLA765, 23KBI086, 23KBL228, 23KBP275, 23KBP461, 23KBT939, 23KDA336, 23LBH647, 23LBH649, 23LBN381, 23LBS862, 23LDB546, 24ABB119, 24ABG696, 24ABH577, 24ABJ684, 24ABK090, 24ABT432, 24ADB783, 24BBC547, 24BBI145, 24BBU253, 24BDB174, 24CBD698, 24CBF216, 24CBF778, 24CBH126, 24CBH771, 24CBM117, 24DBI296, 24DBS813, 24DBU188, 24DBV133 and 24 more |
Product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J
Reason for recall
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
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-1811-2025. 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.