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Stryker Sustainability Solutions: 65 FDA recall reports

Every medical device recall the FDA has published for Stryker Sustainability Solutions. The fault, and how the agency graded it.

65Reports

2Class I

35Ongoing

2026-05-20Most recent

2 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	63
Class I	2

By year reported

Year	Reports
2013	2
2015	5
2016	9
2017	3
2018	6
2019	2
2020	1
2021	2
2022	1
2023	3
2024	3
2025	1
2026	27

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Z-2177-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 427 units

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2174-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 3063 units

Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2191-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 1352 units

BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2181-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 217 units

Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2187-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 108 units

Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2195-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 206 units

BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2176-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 28 units

Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2192-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 107 units

Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2198-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 2 units

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2185-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 816 units

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2183-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 154 units

Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2194-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 10 units

Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2188-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 19 units

Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2199-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 87 units

Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2189-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 9 units

BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2180-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 5 units

Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2186-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 319 units

Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2190-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 24 units

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2179-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.

CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2184-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 449 units

Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2196-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 3 units

Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2197-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 458 units

Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2193-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 3 units

BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2178-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 90 units

BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2175-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 61 units

BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER

Z-2182-2026 · Class II · reported 2026-05-20 · Ongoing

Why it was recalled: Incomplete seals on sterile product
Product: BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Where it went: US Nationwide and the countries of Israel and Canada.
How much: 44 units

Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-23

Z-1804-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Product: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
Where it went: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A
How much: 56,740 cuffs

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single

Z-0490-2026 · Class II · reported 2025-11-19 · Ongoing

Why it was recalled: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
Product: HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Where it went: US Nationwide distribution and OUS (foreign) to country of: Canada.
How much: 22, 476 units

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Z-2689-2024 · Class II · reported 2024-08-28 · Ongoing

Why it was recalled: Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
Product: Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Where it went: US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
How much: 38,850

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Z-2405-2024 · Class II · reported 2024-07-24 · Ongoing

Why it was recalled: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Product: REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Where it went: US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
How much: 90 units

Showing the 30 most recent of 65. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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