CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Craniotomy Pack, Pack Number DYNJ46552O recalled
Medline Industries LP - Northfield is recalling Craniotomy Pack, Pack Number DYNJ46552O, distributed in California, Illinois, Texas. The recall was initiated on 18 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3069-2024
- FDA event ID
- 95127
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Jun 2024
- FDA classified
- 6 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 18 Jun 2024 | Recall initiated by company | |
| 6 Sep 2024 | Classified by FDA | +80 days |
| 18 Sep 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CRANIOTOMY PACK, Pack Number DYNJ46552O
Where it was distributed
US: TX, IL, CA
Questions about this recall
Why was it recalled?
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Which lots are affected?
UDI/DI Case 40195327467044, UDI/DI Each 10195327467043; Lot Numbers: 24ADB788, 23LDA936, 23JDB278, 23HDA872
Where was it sold?
US: TX, IL, CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 95127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Anesthesia Turnover Kit, Pack Number DYNJAA0377A recalled | Medline Industries LP - Northfield | Sterility | CA, IL, TX | |
| CLASS II | Kit Pedi Crani Lami, Pack Number DYNJ907372A recalled | Medline Industries LP - Northfield | Sterility | CA, IL, TX | |
| CLASS II | Anesthesia Turnover Kit, Pack Number DYNJAA0377 recalled | Medline Industries LP - Northfield | Sterility | CA, IL, TX |
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Other Medical Devices recalls
All 13,817| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Percutaneous Insertion Kit (PIK), dilator set recalled | Maquet Cardiopulmonary | Sterility | Nationwide |
| Device | CLASS II | Blood Culture Collection Venipuncture Kit 20/Cs recalled | Medical Action Industries Inc. 306 | Sterility | Nationwide |
| Device | CLASS II | CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled | ICU Medical | Packaging Defects | Nationwide |
| Device | CLASS II | Aisys, Datex-Ohmeda anesthesia system recalled | Datex-Ohmeda | Device Malfunction | Nationwide |