Official recall record
Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT S
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-04-23
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 07613252186922
- Brand on record
- Stryker Neurovascular
What the authority reported
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-04-06 · US FDA — Medical Devices
INZONE DETACHMENT SYSTEM, REF: M00345100950 - 2024-04-23 · US FDA — Medical Devices
DAC 044 115cm, Catalog: 90760 - 2024-04-23 · US FDA — Medical Devices
Trevo Trak 21 Microcatheter, Catalog: 90338
ProductGuru Recalls republishes official safety information with attribution. We are not
the issuing authority and this page is not advice. If this product is a medical device or
medication, speak to a doctor or pharmacist. Found an error?
Report it — corrections are published.