Reprocessed Electrophysiology Catheter Recall Due to Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device with a defect (incomplete seals) that could compromise sterility and create a risk of infection or device malfunction. The source text does not report any illnesses or injuries, placing this in the High category per the rubric for risk-of-harm products without reported adverse events.
Plain-English summary
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters, Product Number 401581, distributed in the US and Canada and Israel. The recall affects 108 units identified by UDI 00885825006877 across multiple lot numbers. The catheters are being recalled due to incomplete seals on the sterile product packaging.
Incomplete seals on sterile medical devices can compromise the sterility assurance of the product. Healthcare providers and patients who have received affected units should consult their healthcare provider regarding the safety and continued use of their device. Patients and healthcare facilities should contact Stryker Sustainability Solutions for instructions on the recalled product.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI 00885825006877
- Lot Numbers: 3683857
- 3836878
- 3981321
- 4042778
- 4053585
- 4103495
- 4496897
- 3683858
- 3891551
- 3991434
- 4052721
- 4053586
- 4111212
- 4496898
- 3694871
- 3932470
- 3991439
- 4052723
- 4103479
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 26 recalled by Stryker Sustainability Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 26 products in this recall →Related recalls
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Similar recalls
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