Facility
SERF
108 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (108)
- Inspections (2)
Devices registered here (1)
- Gauge, DepthProduct code HTJ (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4300
Recalls & enforcement
20267 records
- Class IIOngoing2026-07-01Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
- Class IIOngoing2026-06-08There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
- Class IIOngoing2026-05-06It 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 potential risk of electrical shock due to the device s safety testi…
- Class IIOngoing2026-04-09Due to nonconforming products being inadvertently distributed.
- Class IIOngoing2026-04-06Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure mus…
- Class IIOngoing2026-02-23Surgical light assembly may not adequate support the weight of the ceiling cover.
- Class IIOngoing2026-01-21Due 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.
202510 records
- Class IIOngoing2025-10-31Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
- Class IIOngoing2025-07-15Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
- Class IIOngoing2025-07-02Tourniquet 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 hypotension and cardiovascular collapse and arrest, risking strok…
- Class IIOngoing2025-06-18Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- Class IIOngoing2025-05-28Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
- Class IIOngoing2025-05-22Investigation 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.
- Class IIOngoing2025-03-28The 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.
- Class IIOngoing2025-02-25There 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.
- Class IIOngoing2025-01-29Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
- Class IIOngoing2025-01-08Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.
202411 records
- Class IIOngoing2024-12-03Bolts 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 suction during a procedure.
- Class IIOngoing2024-10-04There 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 to the patient or physician from electrical currents carried t…
- Class IIOngoing2024-09-05May 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, neurosurgical/spinal procedures may be considered a population at greatest risk.
- Class IIOngoing2024-08-30Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.
- Class IICompleted2024-07-24Potential 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 damage or tissue/structure damage from thermal injury which may ne…
- Class IIOngoing2024-06-03Expired Products distributed to customers
- Class IIOngoing2024-05-09The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
- Class IIOngoing2024-04-23Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may inc…
- Class IIOngoing2024-04-18Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Gui…
- Class IIOngoing2024-04-03Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification endotoxin results.
- Class IIOngoing2024-02-08Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.
202312 records
- Class IIOngoing2023-12-06The microcatheter IFU contains an intended use that has not been evaluated by the FDA.
- Class IIOngoing2023-09-13Expired product distributed
- Class IIOngoing2023-09-11An 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.
- Class IIOngoing2023-08-23Expired Product distributed
- Class IIOngoing2023-08-07Potential 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 bio-incompatibility due to components falling into surgical site
- Class IIOngoing2023-07-10Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
- Class IIOngoing2023-06-28There 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).
- Class IIOngoing2023-06-28There 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 package contains a 5820-107-530 device).
- Class IIOngoing2023-03-02Fiber 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.
- Class IIOngoing2023-03-01Not 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 loss, hemorrhage or, in exceedingly rare situations, other major c…
- Class IIOngoing2023-02-07Stryker 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 fixation cannot be locked between 0- 50mm of the threaded rod.
- Class IIOngoing2023-01-25Triton 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 prolongation of postpartum hemorrhage (PPH), or require more aggre…
20223 records
- Class IIOngoing2022-06-03Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
- Class IIOngoing2022-03-28The 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 Nickel sensitivity".
- Class IIOngoing2022-01-14A 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 intervention, or a revision surgery.
20213 records
- Class IIOngoing2021-05-27The devices have a different inner diameter than the diameter specified on the outer box label.
- Class IITerminated2021-02-26Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots.
- Class IIOngoing2021-01-29The manufacturer has become aware that there is a likelihood that the S-Series Equipment Management System Capacitive Touch Controls on the MFRs rotational electrical magnetic brakes may disengage when an electrocautery device is in use.
20204 records
- Class IIOngoing2020-09-25The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.
- Class ITerminated2020-09-21Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
- Class IITerminated2020-05-07Seal integrity of the blister pack may be compromised and sterility cannot be assured
- Class IIOngoing2020-01-07Sterile drapes packaged in an unsealed pouch.
201914 records
- Class IITerminated2019-12-05Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.
- Class IITerminated2019-11-21Pin To Rod Coupling could not clamp the pin and rod as intended
- Class IITerminated2019-10-11The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care P…
- Class IITerminated2019-09-12Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, l…
- Class IITerminated2019-08-01The mounts on the monitor may have an insufficient weld.
- Class IITerminated2019-07-25The seal integrity of the sterile bag containing the kits may be compromised.
- Class IITerminated2019-07-19Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used.
- Class IITerminated2019-04-30The seal integrity of the sterile bag containing the kits may be compromised.
- Class IITerminated2019-04-23There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to specifications and is positioned on the incorrect side that may lead to monitor falling from the monit…
- Class IITerminated2019-04-18A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.
- Class IITerminated2019-04-10The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
- Class IIOngoing2019-03-22The back cover of the light head was insufficiently assembled and could potentially fall off the light.
- Class IITerminated2019-03-07The heated tube sets were consistently leaking and detaching from the cassette.
- Class IITerminated2019-01-21The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
201815 records
- Class IIOngoing2018-11-13There is a potential the joint in the suspension of the device is insufficiently assembled.
- Class IITerminated2018-11-13Labeling error; 8F Balloon Guide Catheters have been packaged within 9F Balloon Guide Catheter packaging
- Class IITerminated2018-08-28The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of t…
- Class IITerminated2018-07-26When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.
- Class IITerminated2018-06-27Incomplete seal on the Tyvek lid may compromise the sterility of the device
- Class IITerminated2018-06-08The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical e…
- Class IITerminated2018-06-05Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
- Class IITerminated2018-05-04Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
- Class IITerminated2018-05-02The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
- Class IITerminated2018-04-27The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.
- Class IITerminated2018-04-11There may be product manufactured with the outer diameter of the balloon catheter exceeding the defined specification at a customer location. If the user experiences resistance between the FlowGate and an interfacing device, the device would be removed and a second device would b…
- Class IITerminated2018-03-12The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
- Class IITerminated2018-01-29The device could have a missing spanner nut and snap ring which could potentially result in the equipment falling.
- Class IITerminated2018-01-26The mounts on the monitor may have an insufficient (missing or incomplete) weld.
- Class IIOngoing2018-01-25The recalled products were shipped without the required temperature control packaging, therefore could potentially have been exposed to elevated temperatures during transit.
20177 records
- Class IICompleted2017-12-21Inadvertent shipment of expired units.
- Class IITerminated2017-11-28Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
- Class IITerminated2017-11-17Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
- Class IITerminated2017-11-03Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.
- Class IITerminated2017-06-26Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
- Class IITerminated2017-04-21The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
- Class IITerminated2017-02-28The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
20166 records
- Class IITerminated2016-10-05Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
- Class IITerminated2016-06-06Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil str…
- Class IITerminated2016-05-04Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction
- Class IITerminated2016-04-12Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of an internal wire breaking upon deployment of the anchor.
- Class IITerminated2016-03-28When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
- Class IITerminated2016-03-21The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
20151 record
- Class IITerminated2015-06-03Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
20146 records
- Class IITerminated2014-11-17The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
- Class IITerminated2014-10-22Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
- Class IITerminated2014-06-20Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
- Class IITerminated2014-05-19STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
- Class IITerminated2014-04-16Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
- Class IITerminated2014-03-17During the use of the SHAPE Arm there is the potential for the monitor mount to come off of the SHAPE Arm if the lock washer and screw are not present.
20136 records
- Class IITerminated2013-11-04Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Class IITerminated2013-08-30When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
- Class IITerminated2013-07-25Potential incomplete final weld on the drop tube flange.
- Class IITerminated2013-06-24The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch l…
- Class IITerminated2013-03-27The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
- Class IITerminated2013-03-05In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
20123 records
- Class IITerminated2012-09-25Stryker has become aware that there is a low likelihood of incomplete engagement of the Spring Arm Circlip during service or replacement of the Spring Arm. If the Spring Arm Circlip is not fully seated, the Spring Arm could separate and fall along with the surgical lights or mon…
- Class IITerminated2012-06-19The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
- Class IITerminated2012-05-21Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.
FDA inspections (2)
- NAI2025-01-30No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2017-09-21Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
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Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “SERF (FEI 3008668801) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008668801-serf/
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