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U.S. Department of Health and Human Services

Class 1 Device Recall Medline

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 Class 1 Device Recall Medlinesee related information
Date Initiated by FirmApril 22, 2025
Date PostedMay 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1811-2025
Recall Event ID 96821
Product Classification Orthopedic tray - Product Code OJH
ProductMedline 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
Code Information 1. CRANI ACCESSORY PACK SKU DYNJ59270 UDI-DI 10888277771512 (ea), 40888277771513 (case) Lots 23JDB683 23JDC548 24ADB783 24HDA822 2. CRANI PACK-LF SKU DYNJ44805M UDI-DI 10195327506872 (ea), 40195327506873 (case) Lots 23JBI747 23KBL228 24ABG696 24CBM117 24EBQ114 24GBJ699 3. CRANIOTOMY SKU CDS982719V UDI-DI 10195327510831 (ea), 40195327510832 (case) Lots 23KBP461 23LBN381 24ABB119 24BBC547 24BBI145 SKU CDS982719W UDI-DI 10195327645090 (ea), 40195327645091 (case) Lots 24DBS813 SKU DYNJ904168F UDI-DI 10195327395728 (ea), 40195327395729 (case) Lots 24DBU188 SKU DYNJ908404B UDI-DI 10195327410506 (ea), 40195327410507 (case) Lots 23IDB680 23LDB546 24BDB174 24FDA741 24FDB584 24IDA225 24IDA646 24IDA840 SKU DYNJ908723A UDI-DI 10195327403270 (ea), 40195327403271 (case) Lots 23IBO314 23JBC218 24ABK090 SKU DYNJ908723C UDI-DI 10198459009785 (ea), 40198459009786 (case) Lots 24IBM205 24IBN365 25ABM356 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A UDI-DI 10195327466466 (ea), 40195327466467 (case) Lots 23JLA765 24DLA724 24DLB006 24ELA325 5. CRANIOTOMY CDS SKU CDS981888X UDI-DI 10195327144760 (ea), 40195327144761 (case) Lots 24ABT432 24CBD698 24HBH954 24HBP483 24IBG797 25CBF098 SKU CDS983467I UDI-DI 10195327457945 (ea), 40195327457946 (case) Lots 23KDA336 6. CRANIOTOMY PACK-LF SKU DYNJ09882G UDI-DI 10195327574055 (ea), 40195327574056 (case) Lots 24CBF778 SKU DYNJ09882I UDI-DI 10198459058172 (ea), 40198459058173 (case) Lots 24HBN426 7. CRANIOTOMY S NASSAU SKU DYNJ905879G UDI-DI 10195327512996 (ea), 40195327512997 (case) Lots 23KBI086 23LBH647 23LBH649 24BBU253 24DBV133 24FBE409 8. MHC CRANIOTOMY SKU DYNJ903713K UDI-DI 10195327201579 (ea), 40195327201570 (case) Lots 23JBK426 SKU DYNJ903713L UDI-DI 10195327531218 (ea), 40195327531219 (case) Lots 23KBT939 23LBS862 24ABH577 24CBH126 24CBH771 9. PAD CRANIOTOMY SKU DYNJ902149J UDI-DI 10195327554323 (ea), 40195327554324 (case) Lots 23KBP275 24ABJ684 24CBF216 24DBI296 24EBD959 24FBF064 24HBK164 24IBN443
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn April 22, 2025, the firm notified customers of the recall through letters titled Immediate Action Required Voluntary Medical Device Recall. Customers were instructed to identify and quarantine all affected product on hand. Customers are to submit a response form to the recalling firm. Upon receipt of the response firm, Medline will provide the customer with over-labels to place on affected inventory, which will include instructions for staff to remove and discard the affected component prior to using the kit. Distributors should notify downstream customers/accounts of this recall. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce1,853 total
DistributionUS distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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