The Recall Desk

Manufacturer

Stryker Sustainability Solutions

65 recalls in our database name Stryker Sustainability Solutions as the manufacturing or recalling firm.

What the numbers show

Total
65
Critical
0
Severe
9
Most recent
2026-05-20

Of the 65 recalls from Stryker Sustainability Solutions we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 65

  • ModerateFDA (Devices)·Z-2195-2026·2026-05-20

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2026·2026-04-15

    Stryker tourniquet cuffs may detach from the bladder welding connection

    Stryker Sustainability Solutions is recalling Color Cuff tourniquet cuffs because the cuff can detach from the bladder at the welding connection, leaving it unable 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)
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0490-2026·2025-11-19

    Reprocessed ultrasonic shears recalled because they may stick in the on position

    Stryker Sustainability Solutions is recalling 22,476 reprocessed HARMONIC FOCUS shears because a manufacturing issue may leave them stuck in the on position, causing continuous activation.

    Product
    HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2024·2024-07-24

    Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling

    Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.

    Product
    REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2268-2024·2024-07-10

    Stryker Diagnostic Electrophysiology Catheters Recalled for Testing Failure

    Stryker Sustainability Solutions is recalling 6 units of BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they do not meet FDA testing requirements. The devices were distributed to Japan.

    Product
    Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2394-2023·2023-08-16

    HoverMatt air transfer mattress contains undersized unit, increases injury risk

    Stryker's HoverMatt 39-inch inflatable transfer mattresses contain 34-inch units inside, reducing available support surface. This increases friction during patient transfers and raises the risk of skin tears.

    Product
    HoverMatt, 39" W x 78" L, REF: HM39SPU-B
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1612-2023·2023-05-24

    Reprocessed DVT Compression Sleeves Recalled Due to Labeling and Packaging Errors

    Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.

    Product
    REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1315-2023·2023-04-05

    Disposable Tourniquet Cuffs Recalled Due to Pressure Failure

    Over 127,000 disposable tourniquet cuffs are being recalled because they may fail to achieve or maintain pressure during surgery due to fabric tearing or O-ring defects, risking operative bleeding and hemorrhage.

    Product
    Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135;
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0664-2022·2022-03-02

    Stryker Color Cuff tourniquet cuff mislabeled as single-bladder when dual-bladder

    Stryker Sustainability Solutions is recalling 40 units of Color Cuff 18" tourniquet cuffs (Lot #12983349) because they are mislabeled as single-bladder when they are actually dual-bladder, creating a risk of incorrect clinical use.

    Product
    REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1327-2021·2021-04-07

    Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance

    Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.

    Product
    Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2020·2021-02-03

    Stryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error

    Stryker is recalling 101 intracardiac ultrasound catheters labeled with incorrect expiration dates, posing risks of sterility breach or component breakdown.

    Product
    Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1802-2020·2020-05-06

    Stryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling

    Stryker Sustainability Solutions is recalling 90 reprocessed Zimmer tourniquet cuffs because they are potentially mislabeled. The mislabeling could lead to device misuse or inadequate limb compression during surgery.

    Product
    Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0973-2019·2019-03-13

    Stryker Reprocessed Arthroscopic Shavers Recalled for Display and Function Errors

    Stryker is recalling 14,265 reprocessed arthroscopic shavers that may display incorrect settings or error messages, preventing proper use during surgery.

    Product
    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0766-2019·2019-01-30

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters Due to Chip Error

    Stryker is recalling 103 reprocessed diagnostic electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0498-2019·2018-12-05

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Distribution Error

    Stryker Sustainability Solutions is recalling 4,848 reprocessed Xcel Bladeless Trocars (H12LP) because they were distributed to facilities after a previous recall was executed.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocess
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0467-2019·2018-11-21

    Stryker Recalls Reprocessed Diagnostic EP Catheters Due to Item Number Error

    Stryker Sustainability Solutions is recalling two reprocessed diagnostic EP catheters because they were identified as item # D134903 but are actually item # D134909, which is not approved for reprocessing.

    Product
    Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2484-2018·2018-07-25

    Stryker Recalls Reprocessed Harmonic Ace Shears Due to Error Code

    Stryker is recalling 180 reprocessed Harmonic Ace shears because they may display an error code preventing use.

    Product
    Reprocessed HARMONIC Ace¿ +7, 5mm Diameter Shears with Advanced Hemostasis (HARH), Item Number HARH36 Product Usage: The Reprocessed HARMONIC ACE¿+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2018·2018-07-18

    Stryker Recalls Reprocessed Coronary Sinus Diagnostic Catheters

    Stryker Sustainability Solutions is recalling 2,722 reprocessed Coronary Sinus Diagnostic EP Catheters because thrombogenicity tests showed they did not meet non-thrombogenic specifications.

    Product
    Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0916-2018·2018-03-14

    Stryker Reprocessed EP Catheters Recalled for EEPROM Chip Error

    Stryker is recalling 170 reprocessed EP catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the card
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0917-2018·2018-03-14

    Stryker Recalls Reprocessed EP Catheters Due to Navigation System Error

    Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the card
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0272-2018·2017-12-27

    Stryker Recalls Mislabeled VenaFlow Calf Compression Garments

    Stryker is recalling 280 VenaFlow Calf Garments mislabeled as Pos-Lock Connectors in Texas due to labeling errors.

    Product
    3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0963-2017·2017-01-18

    Stryker Recalls Reprocessed Ablation Catheter Cables Due to Sterility Concerns

    Stryker is recalling reprocessed ablation catheter cables because a breach in sterile packaging may have resulted in non-sterile product.

    Product
    Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0964-2017·2017-01-18

    Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach

    Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.

    Product
    Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cab
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-0765-2017·2016-12-21

    Stryker Recalls Reprocessed Xcel Bladeless Trocars Due to Plug Breakage

    Stryker is recalling 40,476 reprocessed Xcel Bladeless Trocars because the adjustable plug may break in packaging or during use.

    Product
    Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide