Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile medical device where the hazard—compromised sterility seals—directly impacts product safety and creates a potential for serious infection or adverse health consequences during clinical use. Class II recalls with safety-critical defects in medical devices fall under the Severe category.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable, Product Number 401905, a reprocessed electrophysiology catheter. A total of 107 units with UDI 00885825007270 are affected across 69 specific lot numbers. The product has been distributed nationwide in the United States as well as in Israel and Canada.
The recall was initiated due to incomplete seals on the sterile product. Incomplete seals may compromise the sterility assurance of the catheters, potentially exposing patients to contamination risks during use in electrophysiology procedures.
Healthcare providers and hospitals that have received affected units should discontinue use immediately and contact Stryker Sustainability Solutions for further instructions regarding the affected lot numbers. Patients who may have received treatment with affected catheters should consult their healthcare provider.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 107
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 00885825007270
- Lot Numbers: 4026564
- 4229299
- 4801695
- 4953879
- 4987354
- 5020148
- 5075816
- 4062382
- 4229325
- 4820358
- 4953880
- 4993906
- 5034504
- 5075889
- 4126798
- 4274291
- 4821138
- 4953881
- 4993907
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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