Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The hazard—incomplete sterile seals—is a packaging/quality defect with theoretical risk of compromised sterility, but no reported illnesses or injuries are mentioned in the source text. This fits the rubric for Moderate severity.
Plain-English summary
Stryker Sustainability Solutions is recalling the Daig Livewire Steerable reprocessed electrophysiology catheter (Product Number 401652, UDI 00885825006983) due to incomplete seals on the sterile product packaging.
The incomplete seals could potentially compromise the sterility of the device, creating a risk that the catheter may not maintain its sterile condition prior to use.
The affected product was distributed nationwide in the United States and also to Israel and Canada. The recall involves 24 units across 23 lot numbers (3430230, 4648604, 4945422, 4999751, 5044134, 5059493, 4454505, 4882788, 4950218, 4999755, 5044135, 5086419, 4454517, 4945388, 4993562, 5044132, 5044136, 5086420, 4648603, 4945405, 4993565, 5044133, 5044137).
Affected customers should stop using the product immediately and contact Stryker Sustainability Solutions for instructions on return or replacement.
The recalled product
- Product
- Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- sterile-seal-failure
- sterility-compromise
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 00885825006983
- Lot Numbers: 3430230
- 4648604
- 4945422
- 4999751
- 5044134
- 5059493
- 4454505
- 4882788
- 4950218
- 4999755
- 5044135
- 5086419
- 4454517
- 4945388
- 4993562
- 5044132
- 5044136
- 5086420
- 4648603
Distribution
Distributed nationwide across the United States.