Medtronic Recalls USPACK Suture Kits Due to Potential Seal Defects
Medtronic is recalling USPACK-SUTURE KITs (Item US1672) because an incomplete inner package seal may cause the suture material to degrade prematurely.
What this means for you
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: The recall involves a medical device where a defect (incomplete seal) could lead to product failure (premature degradation), representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medtronic is recalling USPACK-SUTURE KITs, Item Number US1672, due to a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material.
The recall involves 478,465 units distributed worldwide, including the United States (nationwide including Puerto Rico) and countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, South Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.
Healthcare providers and consumers should stop using these suture kits and contact Medtronic for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- USPACK-SUTURE KIT; Item Number: US1672
- Manufacturer
- Medtronic
- Affected units
- 478,465
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 (1)
- A5D0789X
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic 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 8 products in this recall →Related recalls
Same manufacturer · Medtronic
See all →- HighMedtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Best Practice Kits Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect
FDA (Devices) · 2017-06-21
- ModerateMedtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- SevereMedtronic Recalls Custom Suture Packs Due to Potential Seal Defects
FDA (Devices) · 2017-06-21
Same hazard · product degradation
See all →- HighPrescription Nelarabine Injection Recalled for Failed Purity and Degradation Specifications
FDA (Drugs) · 2025-03-12
- HighMorphine Sulfate Extended-Release Tablets Recalled for Impurities and Degradation
FDA (Drugs) · 2024-11-13
- HighCisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards
FDA (Drugs) · 2024-10-23
- HighFosfomycin Tromethamine Granules Recalled for Out-of-Specification Organic Impurities
FDA (Drugs) · 2024-02-28
- ModerateMeloxicam 15 mg tablets recalled for exposure to improper storage temperatures
FDA (Drugs) · 2024-01-03