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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

#4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Lateral Assembly, Radial Head Impl Assembly, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

rHead Recon Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.

Think Surgical

Class I - Dangerous

There is a potential for the cutter head to detach from the cutter shaft.

Mar 30, 2018 Implants & Prosthetics View Details →

AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part Number 2K8017; d. Adult, with mask, 40" oxygen reservoir tubing, Part Number 2K8005; e. Adult, with mask, 40" oxygen reservoir tubing, PEEP valve, Part Number 2K8036; f. Adult, without mask, 40" oxygen reservoir tubing, Part Number 2K8001; g. Adult, with mask, oxygen reservoir bag, manometer, PEEP valve, Part Number 2K8035M; h. Adult, with mask, oxygen reservoir bag, CO2 detector, Part Number 2K8004C2; Manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own. The devices are intended for use as single patient use resuscitator devices for pulmonary resuscitation.

Vyaire Medical

Class I - Dangerous

An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.

May 8, 2018 Diagnostic Equipment Nationwide View Details →

Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism

Smiths Medical ASD

Class I - Dangerous

Certain Barrel Clamp Guides may contain a ridge that could potentially lead to spring slippage, resulting in the inability of the pump to recognize a loaded syringe or the pump, misidentifying the size of a loaded syringe.

Apr 13, 2018 Surgical Instruments Nationwide View Details →

radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.

Arjohuntleigh Magog

Class I - Dangerous

The spreader bar can detach from the scale attachment under certain conditions.

Feb 12, 2018 Other Medical Devices Nationwide View Details →

Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →

143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

ICU Medical

Class I - Dangerous

Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.

Jul 31, 2017 Surgical Instruments Nationwide View Details →

#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Howmedica Osteonics

Class I - Dangerous

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Oct 24, 2017 Implants & Prosthetics Nationwide View Details →