Stryker Neurovascular Recalls INZONE DETACHMENT SYSTEM
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Stryker Neurovascular is recalling 44,937 units of the INZONE DETACHMENT SYSTEM due to premature battery drain that may prevent coil detachment.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 5, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Stryker Neurovascular is recalling the INZONE DETACHMENT SYSTEM because embolization coil detachment system devices may experience premature battery drain. This can cause the devices to not power on, power on with faint audible and visual indicators, or be unable to detach a coil as intended, which may necessitate medical intervention.
Which Products Are Affected
The recall affects the INZONE DETACHMENT SYSTEM, REF: M00345100950. The UDI-DI is 04546540697950. Affected lots include: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985. A total of 44,937 units are affected. Distribution is worldwide, including US nationwide distribution in PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and numerous other countries.
What You Should Do
Consumers and healthcare providers should follow the instructions provided by Stryker Neurovascular for the recall. The recall number is Z-2552-2026.
Why This Matters
The recall involves a Class II medical device distributed worldwide, with potential need for alternative medical intervention during procedures.
Source
FDA Recall Z-2552-2026 - Stryker Neurovascular, Fremont, CA
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,857 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 5, 2026.
Frequently Asked Questions
Common questions about this FDA recall.