Medical device recalls: February 2023

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.

Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence), and failure of implant

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 prolongation of postpartum hemorrhage…

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 prolongation of postpartum hemorrhage…

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 prolongation of postpartum hemorrhage…

Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and…

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425,…

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425,…

Sterile product pouches were not sealed.

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Product Mislabeled on the outer bag and inner kit Tyvek header bag

Label with the incorrect component listed on the inner kit Tyvek header bag

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.

Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are…

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

Delivery Sets may have tubing that could become detached that could result in patient infection.

Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to…

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for…

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for…

The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for…

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Two planers were found to be unusable during sawbones shoulder training.

Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.

The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.

The recall is due to observed intra-operative screw failure. When pre-drilled with 1.3mm drill bit for 2.0mm screws and 1.6mm drill bit for 2.4mm we have observed screw failure due to excessive torque.

Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder…

Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.

Transcranial Doppler/ultrasound system tablet has a faulty hard drive, which will cause the system to freeze and reboot. Initially, the system will reboot to a normal operable state but eventually the system will be rendered inoperable.

Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.