Device recall: MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
Class II FDA enforcement event 95806. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 6 Nov 2024. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 95806 has 10 product records. The first FDA enforcement report date is 1 Jan 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide. Canada.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0717-2025 | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures. | 40 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0718-2025 | FESS-MB PACK-LF Convenience kit, SKU DYNJ0888159I. Convenience kits used for various procedures.. | 36 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0719-2025 | DIEP FLAP Convenience kit, SKU DYNJ910120. Convenience kits used for various procedures. | 26 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0720-2025 | Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK… | 6467 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0721-2025 | Medline brand, medical procedure convenience kits, labeled as: 1) MVFF/FIBU #54-RF , SKU DYNJ21927R; 2) DIEP FLAP, SKU DYNJ910120A | 318 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0722-2025 | SEPTOPLASTY PACK Convenient kit, SKU DYNJ44759F. Convenience kits used for various procedures. | 40 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0723-2025 | Medline brand, medical procedure convenience kits, labeled as: 1) CRANIOTOMY, SKU CDS982719X; 2) MVFF/FIBU #54-RF, SKU DYNJ21927Q; 3) MVFF/FIBU #54-RF, SKU DYNJ21927S; 3) NEURO PEDIATRIC, SKU DYNJ61607A; 4) CRANIOTOMY PACK, SKU DYNJ66419C; 5) LYMPHATIC BYPASS PACK, SKU DYNJ69907; 6) LYMPHATIC BYPASS PACK, SKU… | Class II | Ongoing | 1 Jan 2025 | |
| Z-0724-2025 | Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU… | 12,889 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0725-2025 | KIT,SPINE LH Convenience kit, SKU DYNJ906448A. | 160 kits | Class II | Ongoing | 1 Jan 2025 |
| Z-0726-2025 | Medline brand, medical procedure convenience kits, labeled as: 1) LAMINECTOMY CDS-LF, SKU CDS780045N; 2) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119U; 3) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119V; 4) CRANIOTOMY CDS, SKU CDS981753K; 5) LAMINECTOMY CDS-LF, SKU CDS981923X; 6) CRANIOTOMY, SKU CDS982719Q; 7) CRANIOTOMY,… | 22,970 kits | Class II | Ongoing | 1 Jan 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 10Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-0717-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95806. https://recallregister.com/fda/ii/95806/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide. Canada.
- What quantity of product is in FDA event 95806?
- The event has 10 product records. The first record gives this quantity:
40 kits
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.