Recall archive
121 recalls · page 1 of 6
Reported Aug 12, 2026
STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed…
FDA (openFDA device enforcement)
Reported May 20, 2026
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Due to nonconforming products being inadvertently distributed.
FDA (openFDA device enforcement)
Reported Mar 25, 2026
Cub Pediatric Crib, Model FL19H
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Cribs sold in the USA are missing two access door warning labels.
FDA (openFDA device enforcement)
Reported Feb 25, 2026
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN):…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Dec 17, 2025
Stryker MV3 bariatric bed, Part Number 5900000001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand · Product · Product details · Reason for recall — Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 13, 2025
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood…
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 9, 2025
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — 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,…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2025
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with…
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — 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.…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if…
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Expired Products distributed to customers
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
ProCuity bed series, model number 3009, item number: 300900000000,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — 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…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Expired Product distributed
FDA (openFDA device enforcement)
Reported Sep 27, 2023
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand · Product · Product details — Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 6, 2023
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
Matched: Brand — Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
FDA (openFDA device enforcement)
Reported Jul 19, 2023
Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
Matched: Brand — Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficulty loading/unloading from ambulance, difficulty…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up