Terumo Cardiovascular Procedure Kit Recall for Shipping Damage
Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.
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: This is an FDA Class II recall with no reported injuries or illnesses. The hazard is potential packaging damage with no confirmed harm to products or patients. It qualifies as a voluntary precautionary recall.
Plain-English summary
Terumo Cardiovascular Systems Corp has issued a recall of Cardiovascular Procedure Kit catalog numbers 76645 and 73806 due to packaging damage that occurred during the shipping process.
The recall affects 64 units distributed nationwide in California and Indiana. The affected lot numbers are Z15957677 and Z16958398.
Damaged packaging may affect the condition and usability of the medical devices. Healthcare providers who received these kits should inspect packaging before use.
Customers with affected products should contact Terumo Cardiovascular Systems Corp for instructions on replacement or return.
The recalled product
- Product
- Cardiovascular Procedure Kit catalog # 76645 & 73806
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Hazard
- packaging-damage
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 (5)
- [Lot #Z15957677
- case label GTIN: (01)00699753507685
- product identifier: (17)230228(10)Z15957677] and [Lot #Z16958398
- case label GTIN: (01)00699753477728
- product identifier: (17)230228(10)Z16958398]
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27