Medline custom medical procedure kits labeled as recallZ-0791-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 21, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
Recall details
- Recall number
- Z-0791-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 21, 2024
- Posted by the FDA
- Dec 30, 2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 128 units
- Product code
- MLS
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
Product description
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Code information (models, lots, serial numbers)
UDI/DI 10889942825547 (EA) 40889942825548 (CS), Lot Numbers: 19BKB326, 19DKA892, 19JDA775, 20ADC560
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ0842793DMedline Industries, Inc. · Labor and Delivery Kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95852).
- Z-0777-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRM…
- Z-0778-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYN…
- Z-0779-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4…
- Z-0780-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
- Z-0781-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
- Z-0782-2025 · Open, ClassifiedSee DocMan
- Z-0783-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40…
- Z-0784-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYN…
- Z-0785-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
- Z-0786-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) T…
- Z-0787-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
- Z-0788-2025 · Open, ClassifiedSee DocMan
- Z-0789-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
- Z-0790-2025 · Open, ClassifiedSee DocMan
- Z-0792-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
- Z-0793-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYN…
- Z-0794-2025 · Open, ClassifiedMedline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page