Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-07-29FDA-DeviceBoston Scientific CorporationClass IIAblation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
The needle surface deteriorated due to unexpected electrolysis during procedure.
- 2020-07-29FDA-DeviceBoston Scientific CorporationClass IIAblation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
The needle surface deteriorated due to unexpected electrolysis during procedure.
- 2020-07-29FDA-DeviceBoston Scientific CorporationClass IIAblation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
The needle surface deteriorated due to unexpected electrolysis during procedure.
- 2020-07-29FDA-DeviceMedtronic Xomed, Inc.Class IISoftware 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures.
During internal testing execution of the next generation of Integrated Power Console (IPC) prototype it was noted that the M5 Microdebrider was rotating at a higher speed than the set value in the cosole.
- 2020-07-29FDA-DeviceU&I CORP.Class IIANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
6.0x50mm poly-reduction screws were laser etched 6.0x45
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 00801741066306), LH-0037 (UDI 00801741066320), LH-0038 (UDI 00801741066344), LH-0039 (UDI 00801741066368), LH-0040 (UDI 00801741066382)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IIPowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH-0032YN (UDI 00801741066238), LH-0033YN (UDI 00801741066252), LH-0034YN (UDI 00801741066276), LH-0035YN (UDI 00801741066290 ), LH-0036YN (UDI 00801741066313), LH-0037YN (UDI 00801741066337), LH-0038YN (UDI 00801741066351), LH-0039YN (UDI 00801741066313), LH-0040YN (UDI 00801741066399)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639), PA-0033G (UDI 00801741096433)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set Port Access Kit; Catalog Numbers PA-0029 (UDI 00801741085482), PA-0029YN (UDI 00801741085499), PA-0030 (UDI 00801741085505), PA-0030YN (UDI 00801741085512), PA-0031 (UDI 00801741085529), PA-0031YN (UDI 00801741085536), PA-0032 (UDI 00801741085543), PA-0032YN (UDI 00801741085550), PA-0033 (UDI 00801741085567), PA-0033YN (UDI 00801741085574), PA-0034 (UDI 00801741085581), PA-0034YN (UDI 00801741085598), PA-0036 (UDI 00801741085604), PA-0038 (UDI 00801741085628), PA-0038YN
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IISafeStep Huber Needle Set AllPoints Port Access System; Catalog Numbers AN152075 (UDI 00801741119484), AN152075G (UDI 00801741119583), AN162010 (UDI 00801741119682), AN162010G (UDI 00801741119446), AN162075 (UDI 00801741119675), AN162075G (UDI 00801741119439)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IIPowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IIPowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IIPowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceBecton Dickinson & CompanyClass IIPowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IIThora-Para 5 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IIThora-Para 8 Fr Catheter Drainage Tray w/o Lidocaine
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IIThora-Para 8 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T-Centesis 8 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T-Centesis 6 Fr Catheter Drainage Tray w/o Lidocaine
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T-Centesis 6 Fr Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
- 2020-07-29FDA-DeviceCarefusion 2200 IncClass IISafe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
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