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Device recall: Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiologic

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing."

Q: What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Q: Where was the product distributed?

FDA's distribution pattern field reads: "US: KS OUS: None"

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Feb 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Q: Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

FDA enforcement event 81321 · Class II · initiated 23 Aug 2018 · status Terminated · terminated 4 Feb 2021

DeviceVoluntary: Firm initiated1 product recordTempe, AZ

Stryker Sustainability Solutions (Tempe, AZ) initiated this device recall on 23 Aug 2018; FDA lists 1 product record under event 81321, classified Class II.

FDA defines Class II as 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 4 Feb 2021. Initiation: voluntary: firm initiated. Stryker Sustainability Solutions has 36 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Stryker Sustainability Solutions, Tempe, AZ.

Reason for recall

"Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing."

Distribution

"US: KS OUS: None"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0467-2019	Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.	2	Class II	Terminated	21 Nov 2018

Context

92%of 2018 device events are Class II1,074 events that year

1product record in this eventfirm median: 1

36events on this register for the firm

Other enforcement events for Stryker Sustainability Solutions

Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM	Device	Class II	6
10 Apr 2026	BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER	Device	Class II	26
12 Mar 2026	Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker	Device	Class II	1
24 Sep 2025	HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO	Device	Class II	1
2 Jul 2024	Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A	Device	Class II	1
31 May 2024	REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly	Device	Class II	1
10 May 2024	Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, s	Device	Class II	1
21 Jun 2023	HoverMatt, 39" W x 78" L, REF: HM39SPU-B	Device	Class II	1
14 Apr 2023	REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile	Device	Class II	1
1 Mar 2023	Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bl	Device	Class II	1

All 36 events for Stryker Sustainability Solutions

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "US: KS OUS: None"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Feb 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.