Stryker recalls
33 official recalls and safety alerts involving Stryker since 2022-03, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Stryker or the relevant agency.
- 2026-08-12
USStryker Corporation recalls STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Australia, Brazil,…Official notice →- 2026-08-05
- US
Stryker GmbH recalls Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
FDA · DeviceStryker GmbHWorldwide - US Nationwide distribution including in the states of AL, AZ, CA,…Official notice → - 2026-06-10
- US
Stryker Corporation recalls Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a…
- 2026-05-20
- US
Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the…
Due to nonconforming products being inadvertently distributed.
- 2026-02-25
- US
Stryker Corporation recalls MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009…
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.
FDA · DeviceStryker CorporationWorldwide - U.S. Nationwide distribution including in the states of AL, AK,…Official notice → - 2025-12-03
- US
Stryker Corporation recalls NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita;…
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2025-08-13
- US
Stryker Corporation recalls Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK /…
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral…
FDA · DeviceStryker CorporationDomestic US distribution nationwide. International distribution to Australia…Official notice → - 2025-07-30
- US
Stryker Corporation recalls Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2025-06-18
- US
Stryker GmbH recalls Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.
FDA · DeviceStryker GmbHWorldwide - US Nationwide distribution in the states of California and…Official notice → - US
Stryker GmbH recalls Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
FDA · DeviceStryker GmbHWorldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the…Official notice → - 2025-04-23
- US
Stryker GmbH recalls Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
FDA · DeviceStryker GmbHUS Nationwide distribution in the states of CA, GA, IL, KY, MA, MD, NY, OH,…Official notice → - 2025-04-09
- US
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.
- 2025-03-19
- US
Stryker Corporation recalls Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2025-02-19
- US
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
- 2025-01-29
- US
Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of UK, Netherlands,…Official notice → - 2025-01-15
- US
Stryker Corporation recalls 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V…
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of…
FDA · DeviceStryker CorporationUS (Domestic) distribution to states of: WA, GA, and IL. OUS (International)…Official notice → - 2024-11-20
- US
Stryker Corporation recalls Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including…
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Canada, Japan,…Official notice → - 2024-10-23
- US
Stryker Corporation recalls 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement…
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus,…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Canada, Columbia.Official notice → - 2024-09-04
- US
Stryker Corporation recalls Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating,…
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure…
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2024-07-10
- US
Stryker Corporation recalls The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood…
Expired Products distributed to customers
FDA · DeviceStryker CorporationUS Nationwide distribution in the states of Arkansas, California, Colorado,…Official notice → - 2024-07-03
- US
Stryker GmbH recalls Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
FDA · DeviceStryker GmbHWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice → - 2024-02-21
- US
Stryker, Inc. recalls Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
FDA · DeviceStryker, Inc.US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH,…Official notice → - 2023-11-15
- US
- US
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
FDA · DeviceStryker CorporationUS Nationwide. Australia, Canada, Japan, Korea, Singapore.Official notice → - 2023-10-04
- US
Stryker Corporation recalls Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Expired Product distributed
FDA · DeviceStryker CorporationUS Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ,…Official notice → - 2023-09-27
- US
Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and…
FDA · DeviceStryker CorporationNationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy…Official notice → - 2023-09-06
- US
Stryker Corporation recalls SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and…
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
- 2023-05-10
- US
Stryker Corporation recalls SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of PA, MS, IL,…Official notice → - 2023-04-12
- US
Stryker Corporation recalls Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use…
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood…
- 2023-03-08
- US
Stryker GmbH recalls stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone…
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring…
- US
Stryker Corporation recalls Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or…
- 2022-05-04
- US
Stryker GmbH recalls Smart Toe II Intramedullary Arthrodesis Implant
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with…
FDA · DeviceStryker GmbHWorldwide distribution - US Nationwide and the countries including Australia,…Official notice → - 2022-03-16
- US
Stryker Corporation recalls 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and…
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical…
FDA · DeviceStryker CorporationWorldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL,…Official notice →