Stryker recalls specific Synchro2 guidewires with hydrophilic coating that may have manufacturing defects. Affected units include certain lot numbers and product codes. Consumers should check their product details and contact Stryker for instructions.
See the official notice for the full hazard description.
Stryker is recalling specific Synchro2 guidewires with hydrophilic coating due to potential manufacturing defects. This recall affects medical devices used in intravascular procedures, and users should verify their product details to determine if they are impacted.
The recall is for potential manufacturing defects in the hydrophilic coating of the guidewire. These defects could lead to improper function during medical procedures, but the specific hazard mechanism is not clearly described in the recall notice.
Medical professionals who use Stryker Synchro2 guidewires for intravascular procedures may be affected. Patients using these devices during surgery are at risk if they have the recalled product.
Check for the product code UPN M00326310 and lot numbers listed in the recall notice. The affected guidewires are 0.014in x 300cm with hydrophilic coating and were manufactured with specific serial numbers.
Verify your guidewire's product code and lot numbers against the list provided in the recall notice.
The recall notice states potential manufacturing defects in the hydrophilic coating, but does not specify the exact hazard mechanism.
Check for the product code UPN M00326310 and lot numbers listed in the recall notice, such as 0000000563 or 0000000986.
Contact Stryker directly for instructions on how to handle the affected product.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-0227-2020 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-0227-2020 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
