Food, drugs, devices › Stryker Sustainability Solutions

Device recall: REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Q: Why was this device recalled?

FDA's record gives the reason for recall as: "Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs."

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 OK TX OUS: None"

Q: Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Feb 2025. "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 89535 · Class II · initiated 21 Jan 2022 · status Terminated · terminated 26 Feb 2025

DeviceVoluntary: Firm initiated1 product recordTempe, AZ

FDA enforcement event 89535 is a device recall by Stryker Sustainability Solutions of Tempe, AZ, initiated 21 Jan 2022 and classified Class II, with 1 product record.

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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 26 Feb 2025. 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

"Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs."

Distribution

"US: KS OK TX OUS: None"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0664-2022	REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder	40 units	Class II	Terminated	2 Mar 2022

Context

88%of 2022 device events are Class II839 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: "Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs."

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 OK TX OUS: None"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Feb 2025. "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.