Medline Kits containing Codman Disposable Perforator 14 mm: 1 — Class I medical device recall Z-1809-2025
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-1809-2025 |
|---|---|
| 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 | 10195327466626, 10195327539153, 10195327561116, 10195327575571, 10195327635466, 10195327637392, 40195327466627, 40195327539154, 40195327561117, 40195327575572, 40195327635467, 40195327637393 |
| Lot numbers | 23KBA720, 23LBI611, 23LBJ586, 24ADA818, 24ADC216, 24AMF811, 24BDA929, 24BMD310, 24CBB843, 24CMA496, 24DDB447, 24EBC889, 24EDA275, 24EDA751, 24EMI836, 24GBY029, 24GDB213, 24HMI081, 24HMI978, 24IDA327, 24IDB043 |
Product
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
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-1809-2025. 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.