Data Foundry

Medical device recalls 2025

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 numberZ-1811-2025
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-04-22
Classified2025-05-30
Reported by FDA2025-06-11
DistributedCA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA, WI
Quantity1,853 total
Reason classesdevice malfunction
UPC / GTIN / UDI-DI10195327144760, 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 numbers23IBO314, 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.