Tempe, AZ, United States
Stryker Sustainability Solutions recalls
22 recalls recorded since 2018, most recently on 19 August 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls22
Ongoing (FDA)12
Terminated or completed10
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 August 2026
- Reason
- Reusable access port system may crack or seperate during use.
- Distribution
- US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Mis
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3183-2026, Z-3187-2026, Z-3186-2026, Z-3185-2026, Z-3184-2026, Z-3182-2026
- REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
- REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
- REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
- REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
- REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
- REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Ongoing Class II Medical devices
- Recall started
- 18 August 2026
- Reason
- Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
- Distribution
- US Nationwide distribution in the state of NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0085-2027
- BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
Ongoing Class II Medical devices
- Recall started
- 10 April 2026
- Reason
- Incomplete seals on sterile product
- Distribution
- US Nationwide and the countries of Israel and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2177-2026, Z-2174-2026, Z-2191-2026, Z-2181-2026, Z-2187-2026, Z-2195-2026, Z-2176-2026, Z-2192-2026, Z-2198-2026, Z-2185-2026, Z-2183-2026, Z-2194-2026 and 14 more
- BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
- BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
- and 18 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 March 2026
- Reason
- 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.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1804-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 24 September 2025
- Reason
- Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
- Distribution
- US Nationwide distribution and OUS (foreign) to country of: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0490-2026
- HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
Ongoing Class II Medical devices
- Recall started
- 2 July 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2689-2024
- Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Ongoing Class II Medical devices
- Recall started
- 31 May 2024
- Reason
- Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
- Distribution
- US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2405-2024
- REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
- Distribution
- International distribution to the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2268-2024
- 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
Ongoing Class II Medical devices
- Recall started
- 21 June 2023
- Reason
- 39-inche-wide inflatable air transfer mattress packages contain 34-Inch-wide mattresses, so there may be a decreased surface area available to distribute the patient's weight across, which may increase the effort exerted by staff for a lateral patient transfer, and there may be increased friction and shearing forces when the patient is moved resulting in skin tear injury.
- Distribution
- US: WI, ID, CA, FL, HI, MD, RI, AZ, MA, GA, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2394-2023
- HoverMatt, 39" W x 78" L, REF: HM39SPU-B
Ongoing Class II Medical devices
- Recall started
- 14 April 2023
- Reason
- Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
- Distribution
- US: WA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1612-2023
- REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
Ongoing Class II Medical devices
- Recall started
- 1 March 2023
- Reason
- Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
- Distribution
- US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1315-2023
- 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, Si
Terminated Class II Medical devices
- Recall started
- 21 January 2022
- Terminated
- 26 February 2025
- Reason
- Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
- Distribution
- US: KS OK TX OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0664-2022
- REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
Ongoing Class II Medical devices
- Recall started
- 19 January 2021
- Reason
- Product was distributed without receiving regulatory clearance.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1327-2021
- 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 m
Terminated Class II Medical devices
- Recall started
- 27 March 2020
- Terminated
- 14 October 2022
- Reason
- A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.
- Distribution
- US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2113-2020
- 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
Terminated Class II Medical devices
- Recall started
- 9 October 2019
- Terminated
- 14 January 2021
- Reason
- Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
- Distribution
- US Nationwide distribution including the states of SC, TX, UT, NY, AR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1802-2020
- 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
Terminated Class II Medical devices
- Recall started
- 17 December 2018
- Terminated
- 8 December 2023
- Reason
- Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are used with CARTO(R) EP Navigation Systems.
- Distribution
- US distribution to states of: GA, KS, MO FL, CA, WA, IA,; and internationally to: Germany, Japan and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0766-2019
- 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 end
Terminated Class II Medical devices
- Recall started
- 23 August 2018
- Terminated
- 4 February 2021
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
Terminated Class II Medical devices
- Recall started
- 27 July 2018
- Terminated
- 17 September 2020
- Reason
- Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
- Distribution
- Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. OUS Israel and Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0973-2019
- 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 surge
Terminated Class II Medical devices
- Recall started
- 19 June 2018
- Terminated
- 15 November 2024
- Reason
- Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.
- Distribution
- US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0498-2019
- 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 obturat
Terminated Class II Medical devices
- Recall started
- 8 May 2018
- Terminated
- 29 July 2019
- Reason
- Stryker Sustainability Solutions has received an increase in reports indicating that the affected Reprocessed HARH36 devices may display an error code (No Instrument Uses Remaining) upon initial connection to the generator. When this error code is present, the device is not able to be used.
- Distribution
- US Nationwide Distribution in the states of PA, FL, MD, MA, CA, NY, NC, TX, MT, AL, LA, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2484-2018
- 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 so
Terminated Class II Medical devices
- Recall started
- 29 March 2018
- Terminated
- 28 July 2020
- Reason
- Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
- Distribution
- Worldwide Distribution - US Nationwide and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2426-2018
- 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 mapp
Terminated Class II Medical devices
- Recall started
- 2 January 2018
- Terminated
- 2 May 2018
- Reason
- An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
- Distribution
- USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0916-2018, Z-0917-2018
- 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
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.