BARD Dynamic Tip Steerable Medical Device Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable devices due to incomplete seals on the sterile product. The recall affects 427 units distributed nationwide and in Israel and Canada.
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 medical device recall. Incomplete seals on a sterile device create a risk of contamination or loss of sterility, which could harm users. No illnesses or injuries are reported in the source text, but the hazard is concrete rather than theoretical.
Plain-English summary
Stryker Sustainability Solutions is recalling the BARD Dynamic Tip Steerable, Product Number 6DYNTP001. The recall was initiated because some units have incomplete seals on the sterile product, which could compromise the sterility of the device.
The affected product includes 427 units with UDI 00885825005528 and multiple lot numbers. These units were distributed throughout the United States, Israel, and Canada.
Consumers who have received or are using this product should contact Stryker Sustainability Solutions for instructions on how to proceed. Healthcare providers and patients should not use affected units to ensure product safety and integrity.
The recalled product
- Product
- BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Sterile Device
- Affected units
- 427
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 00885825005528
- Lot Numbers: 3495675
- 4117216
- 4330131
- 4471121
- 4553575
- 4630179
- 4768595
- 4821705
- 4954755
- 5043512
- 3684287
- 4129638
- 4334639
- 4471122
- 4554838
- 4630180
- 4773075
- 4821706
- 4954759
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
Same manufacturer · Stryker Sustainability Solutions
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighIncisive Surgical Recalls INSORB Subcuticular Skin Staplers Due to Sterility Concerns
FDA (Devices) · 2018-10-17
- HighStryker Recalls Endotrac Hook/Triangle Blade Kits Due to Seal Integrity
FDA (Devices) · 2019-06-26
- HighStradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
FDA (Devices) · 2022-12-21
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighMedtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
FDA (Devices) · 2014-11-26
- ModerateBard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error
FDA (Devices) · 2017-05-31