FDA (Devices) recall action 98708

Stryker Sustainability Solutions recalled 26 products on 2026-05-20

The FDA (Devices) publishes a recall like this one as 26 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 26 pages.

Products: 26
Announced: 2026-05-20
Critical: 0
Units: 8,061

Why these products were recalled

Incomplete seals on sterile product

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 26

HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.
Product
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 154 units of BW Webster Duo-Decapolar reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Product
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable electrophysiology catheters with incomplete seals on sterile packaging. The defect may allow contamination of the sterile product.
Product
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.
Product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed electrophysiology catheters recalled over incomplete sterile seals
The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter is being recalled because of incomplete seals on the sterile product. 449 units are affected.
Product
CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall
Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.
Product
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
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.
Product
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200344) due to incomplete seals on sterile product packaging that could compromise sterility.
Product
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
SevereFDA (Devices)··2026-05-20
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.
Product
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable BDB Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.
Product
Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals
Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Daig Livewire Steerable recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product. The recall affects 19 units distributed nationwide in the US, Israel, and Canada.
Product
Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
BARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.
Product
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
SevereFDA (Devices)··2026-05-20
BARD Dynamic XT Deca Steerable electrophysiology catheter Class II recall
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.
Product
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Medtronic Marinr Steerable Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling 87 units of the Medtronic Marinr Steerable reprocessed electrophysiology catheter (Product Number 72402) due to incomplete seals on the sterile product.
Product
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable Reprocessed Electrophysiology Catheters Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging. The defect may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
SevereFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals Recalled
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.
Product
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.
Product
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recall Due to Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling 108 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The defect may compromise sterility assurance.
Product
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall
Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.
Product
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
SevereFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheters Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
Product
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
ModerateFDA (Devices)··2026-05-20
Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.
Product
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states
HighFDA (Devices)··2026-05-20
Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals
Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which could compromise sterility.
Product
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Distribution
0 states