Stryker Corporation recalls
Every recall we track for Stryker Corporation — 112 in all, from 2017–2026 — plus the complaints and injury reports the public filed about them. 4 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Stryker Corporation peaked in 2023 (42); 112 since 2017. 4% rated “stop using now”.
All FDA recall records for Stryker Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 5 | 0 | 5 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 8 | 0 | 0 | 8 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 1 | 0 | 0 | 1 |
| 2023 | 1 | 17 | 24 | 0 | 42 |
| 2024 | 2 | 8 | 11 | 0 | 21 |
| 2025 | 1 | 1 | 21 | 0 | 23 |
| 2026 (to date) | 0 | 2 | 4 | 2 | 8 |
Most common reasons for Stryker Corporation recalls
What to do if you have a recalled Stryker Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Stryker Corporation recalls
35 shown- Lower riskMedical device
Stryker Corporation recalls STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
Stryker recalls AHTO Tube Set Packaging (Catalog 0250070600) due to reported leaking from handpieces during use. Affected units include specific batch numbers.
StrykerJun 8, 2026 - UnratedMedical device
Stryker Corporation recalls Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System
Stryker recalls Neptune Smart Docking Station (120V) due to potential electrical shock from incomplete safety testing. Affected units may not have passed required testing before shipping.
StrykerMay 6, 2026 - UnratedMedical device
Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be
Stryker recalls FluidSmart Urology Tube Set REF LL0006 with UDI-DI code 00860936000365 due to nonconforming products being inadvertently distributed. Affected units may have safety risks.
StrykerApr 9, 2026 - Lower riskMedical device
Stryker Corporation recalls MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN):
Stryker recalls MOLLI 2 System surgical tools due to outdated labeling that may affect marker placement during procedures. Affected units include specific model numbers and serial ranges.
StrykerJan 21, 2026 - Lower riskMedical device
Stryker Corporation recalls NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's
Stryker recalls NICO BrainPath Shephard's Hook devices with latex in packaging tape. Latex may cause allergic reactions. Affected models include NN-8024, NN-8025, NN-8026, and NN-8042.
StrykerOct 31, 2025 - Stop using nowMedical device
Stryker Corporation recalls Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP
Stryker recalls disposable tourniquets that may detach during use, causing bleeding, stroke, or death. Affected models include 5921-018-135 and others. Stop using immediately if you have these items.
StrykerJul 2, 2025 - Lower riskMedical device
Stryker Corporation recalls Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Stryker recalls disposable suction/irrigator units with disposable tips due to potential irrigation solution leaking into handpiece and battery pack, causing malfunction.
StrykerJun 18, 2025 - Lower riskMedical device
Stryker Corporation recalls Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL
Stryker recalls Otopore Cylinder outer ear wound dressings with specific catalog numbers and lot ranges due to potential sterility seal breaches that could compromise infection control.
StrykerFeb 25, 2025 - Use cautionMedical device
Stryker Corporation recalls Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Stryker recalls CinchLock Flex Knotless Anchor with Inserter due to reported pullwire breakage that may leave broken wire inside the implant body after surgery.
StrykerJan 29, 2025 - Lower riskMedical device
Stryker Corporation recalls stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Stryker recalls Precision Thin blades (REF 2296-003-155) that may not securely fit handpieces due to measurement issues. Affected units include specific lot numbers and GTIN.
StrykerJan 8, 2025 - Use cautionMedical device
Stryker Corporation recalls 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH
Stryker recalls Neptune 3 Rover and S Rover models with loose bolts that could cause suction failure during procedures. Affected units have specific model numbers and lot numbers.
StrykerDec 3, 2024 - Stop using nowMedical device
Stryker Corporation recalls Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical
Stryker recalls Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils that may activate without manual input, risking electrical burns during surgery. Affected units include specific lot numbers and catalog codes.
StrykerOct 4, 2024 - Use cautionMedical device
Stryker Corporation recalls 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of
Stryker recalls 1.2mm Cross Cut Fissure surgical tools due to potential endotoxin levels causing fever, inflammation, and meningitis in neurosurgical procedures. Affected items have specific catalog and lot numbers.
StrykerSep 5, 2024 - Lower riskMedical device
Stryker Corporation recalls Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,
Stryker recalls certain iBur 3.0mm Coarse Diamond Round surgical burs for potential thermal injury during bone procedures. Affected units may cause minor tissue damage requiring medical attention.
StrykerJul 24, 2024 - Lower riskMedical device
Stryker Corporation recalls The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially
Stryker recalls expired Non-Sterile Flyte hood covers for potential product expiration risks. Learn about affected items and what to do.
StrykerJun 3, 2024 - Lower riskMedical device
Stryker Corporation recalls Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe,
Stryker recalls Portal Entry Kit (lot #007047) due to expired product. This kit includes skin marker, ruler, FlexSticks, syringe and needles. No action needed as expired product is not a safety hazard.
StrykerSep 13, 2023 - Lower riskMedical device
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
Stryker recalls disposable Spetzler-Malis bipolar forceps with incorrect 54-month expiration date label; actual shelf life is 36 months. Affected items may expire sooner than intended.
StrykerSep 11, 2023 - Lower riskMedical device
Stryker Corporation recalls Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
Stry: Stryker recalls expired Cinchlock SS Knotless Anchor Inserter (Part CAT02462, Lot 19175AE2) due to expired product. Consumers should check if their item matches the lot number and contact Stryker for details.
StrykerAug 23, 2023 - Stop using nowMedical device
Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement
Stryker recalls ACM bone cement kits with a breakaway femoral nozzle that may disassemble during use, risking surgical site contamination. Affected units include specific lot numbers from 2022-2023.
StrykerAug 7, 2023 - Lower riskMedical device
Stryker Corporation recalls SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting,
Stryker recalls SurgiCount+ software version 2.1.8 and 2.20 that may miscount sponges during surgery due to scanning multiple sponges from the same pack type.
StrykerJul 10, 2023 - Lower riskMedical device
Stryker Corporation recalls The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during
Stryker recalls a specific neurosurgery bur model due to potential mismatch between package contents and outer label. This could lead to using the wrong device during surgery. Affected units include the 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) with GTIN 04546540362483.
StrykerJun 28, 2023 - Use cautionMedical device
Stryker Corporation recalls stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Stryker recalls 3.0MM Neuro Match Heads with potential label mismatch between package and outer label, risking incorrect surgical device use during neurosurgery.
StrykerJun 28, 2023 - Lower riskMedical device
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
Stryker recalls specific SafeLight fiber optic cables due to potential light output issues that could delay medical procedures. Affected units include clear and gray 5mm x 10ft cables with certain reference numbers.
StrykerMar 2, 2023 - Use cautionMedical device
Stryker Corporation recalls Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS
Stryker recalls disposable tourniquet cuffs that may not hold pressure properly, risking blood loss during surgery. Affected units include specific catalog numbers and lot dates. Contact Stryker for details.
StrykerMar 1, 2023 - Use cautionMedical device
Stryker Corporation recalls Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Stryker recalls Triton Canister Software (GAUS-2) that may cause inaccurate blood loss estimates, potentially leading to delayed recognition or prolonged postpartum hemorrhage.
StrykerJan 25, 2023 - Use cautionMedical device
Stryker Corporation recalls 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear
Stryker recalls 1688 Camera Control Units with software defects causing image flips, risking surgical errors. Affected units have specific serial numbers and software versions.
StrykerJan 14, 2022 - Lower riskMedical device
Stryker Corporation recalls Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049
Stryker recalls PINPOINT Video Processor/Illuminators that may flicker, lose image, or reboot unexpectedly. This medical device is used with SPY-PHI and PINPOINT systems for imaging. Affected units have specific UDI codes.
StrykerFeb 26, 2021 - Lower riskMedical device
Stryker Corporation recalls Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/
Stryker recalls Spy-Phi Drape (HH2000) and Spy-Phi Pack (HH9006) in the US due to sterile drapes packaged in unsealed pouches. Affected units have specific lot numbers.
StrykerJan 7, 2020 - Use cautionMedical device
Stryker Corporation recalls Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01)
Stryker recalls 5.0mm x 45cm Strykeprobe outer sheath replacements due to potential electrical hazards from improper seating of the sheath/probe tip.
StrykerSep 12, 2019 - Use cautionMedical device
Stryker Corporation recalls Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-471, UDI 07613327464818, Sterile R, RX Only
Stryker recalls Omega 4.75mm PEEK Knotless Anchor Systems due to difficulty removing the driver, which may cause screws to pull out and create additional bone injury sites.
StrykerJul 19, 2019 - Use cautionMedical device
Stryker Corporation recalls Stryker Connected OR Cart,120 V Ref Cat. #240-099-155, Qty 1, Rx Only, Manufactured for: Stryker, 5900 Optical Court,
Stryker recalls a specific medical cart model due to a risk of monitor falling from the cart, potentially causing injury. Affected units have a unique serial number and were sold in 2019.
StrykerApr 23, 2019 - Use cautionMedical device
Stryker Corporation recalls Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx,
Stryker recalls High Flow II Tube Set (REF 0620-040-660) due to consistent leaking and detachment from the PNEUMO SURE High Flow Insufflator, posing a risk of improper use during medical procedures.
StrykerMar 7, 2019 - Lower riskMedical device
Stryker Corporation recalls CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI
Stryker recalls collagen-based meniscus implants that may have been exposed to high temperatures during shipping, potentially affecting safety. Learn which models are affected and what to do.
StrykerJan 25, 2018 - Lower riskMedical device
Stryker Corporation recalls 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is
Stryker recalls 5-unit boxes of disposable cannulas with expired expiration dates (August 2018 marked but should be 2016). Affected units may pose safety risks if used after expiration.
StrykerDec 21, 2017 - Lower riskMedical device
Stryker Corporation recalls STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
Stryker recalls certain ACL Interface Screws (Model 0234010056) due to higher bioburden levels in some lots. Affected items may pose infection risks during surgery.
StrykerNov 17, 2017
Stryker Corporation recall questions
How many recalls has Stryker Corporation had?
112 recalls from Stryker Corporation are on record with U.S. safety agencies, from 2017–2026.
What is the most recent Stryker Corporation recall?
Stryker Corporation recalls STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600, dated Jun 8, 2026. Every Stryker Corporation recall is listed on this page, newest first.
Why are Stryker Corporation products recalled?
The most common reasons on record: Expired Products distributed to customers (3); The heated tube sets were consistently leaking and detaching from the cassette. (3); Sterile drapes packaged in an unsealed pouch. (2).
What should I do if I have a recalled Stryker Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Stryker Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.