Other Medical Devices Recalls

Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, Phaneuf Hysterectomy Forceps STR 210MM; (2) REF BJ501R, Phaneuf Hysterectomy Forceps ANG 205MM; (3) REF BJ511R, Holzbach Hyst Forceps CVD245MM; (4) REF BJ520R, Heaney Hyst Forceps Grooved 205MM; (5) REF BJ521R, Heaney Hyst Forceps Grooved 250MM; (6) REF BJ522R, Heaney Hyst Forceps Grooved 195MM; (7) REF BJ524R, Heaney-Rezek Fcpsstr Ser Lgth 210MM; (8) REF BJ527R, Wiener Hyst Forceps Grooves 240MM; (9) REF BJ530R, Heaney Hysterectomy Forceps STR 225MM; (10) REF BJ531R, Heaney Hysterectomy Forceps CVD200MM; (11) REF BJ532R, Heaney Hysterectomy Forceps CVD215MM; (12) REF BJ534R, Hysterectomy For.Gwilliamsstr.205MM; (13) REF BJ550R, Wertheim Parametrium Clamp STR 250MM; (14) REF BJ551R, Wertheim Parametrium Clamp CVD245MM; (15) REF BJ552R, Wertheim Parametrium Clamp CVD240MM; (16) REF BJ553R, Wertheim Parametrium Clamphvy-CVD220MM; (17) REF MD591, Heany Ballentine Hyst Fcps STR.215MM; and (18) REF MD592, Heany Ballentine Hyst Fcps CVD.215MM.

Aesculap

Class I - Dangerous

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Jan 31, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

Smiths Medical ASD

Class I - Dangerous

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

Feb 13, 2025 Other Medical Devices Nationwide View Details →

Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Carrel Artery Forceps 85MM; (2) REF BH104R, Hartmann Mosquito FCSDEL STR 100MM; (3) REF BH105R, Hartmann Mosquito FCPSDELCVD100MM; (4) REF BH108R, Micro-Halsted Forceps DEL STR125MM; (5) REF BH109R, Micro-Halsted Forceps DEL CVM 125mm; (6) REF BH114R, Hartmann Mosquito FCPSDELSTR1X2100MM; (7) REF BH115R, Hartmann Mosquito FCPSDELCVD1X2100MM; (8) REF BH118R, Micro-Halsted FCPS Del STR 1X2125MM; (9) REF BH119R, Micro-Halsted FCPS Del CVD 1X2125MM; (10) REF BH120R, Halsted-Mosquito FCPSDELSTR1X2125MM; (11) REF BH121R, Halsted-Mosquito FCPS DELCVD1X2125MM; (12) REF BH130R, Providence-Hosp FCPS Del STR140MM; (13) REF BH131R, Providence-Hosp FCPS Del CVD 140MM; (14) REF BH134R, Kelly Forceps Del STR 140MM; (15) REF BH135R, Kelly Forceps Del CVM 140MM; (16) REF BH139R, Dandy Delicate Forceps CVD140MM; (17) REF BH140R, Baby Crile Forceps Del STR 140MM; (18) REF BH141R, Baby Crile FORCEPSDELCVD140MM; (19) REF BH143R, Dandy Del FCPS LAT-CVD 1X2 140MM; (20) REF BH144R, Crile Forceps STR 140MM; (21) REF BH145R, Crile Forceps CVD 140MM; (22) REF BH150R, Baby Kocher Forceps STR 140MM; (23) REF BH151R, Kocher Forceps Del CVD 1X2140MM; (24) REF BH154R, Crile Forceps Del STR 1X2 140MM; (25) REF BH155R, Crile Forceps Del CVD 1X2 140MM; (26) REF BH160R, Leriche Delicate Forceps STR 150MM; (27) REF BH161R, Leriche Delicate Forceps CVD 150MM; (28) REF BH164R, Rankin FCPS Long Kelly Del STR160MM; (29) REF BH166R, Crile Forceps STR 160MM; (30) REF BH170R, Leriche Delicate Forceps STR 1X2150MM; (31) REF BH171R, Leriche Delicate Forceps CVD1X2150MM; (32) REF BH176R, Crile Forceps STR 1X2160MM; (33) REF BH177R, Crile Forceps CVD 1X2 160MM; (34) REF BH178R, Dixon-Lovelace Artery FCPS.1X2T.STR.160; (35) REF BH197R, Birkett Delicate Forceps CVD185MM; (36) REF BH199R, Nissen Delicate Forceps CVP 185MM; (37) REF BH200R, Adson Delicate Forceps STR185MM; (38) REF BH201R, Adson Delicate Forceps CVD 185MM; (39) REF BH202R, Halsted Delicate Forceps STR 185MM; (40) REF BH203R, Halsted Delicate Forceps CVD 185MM; (41) REF BH205R, Adson Hemostatic FCPS CVD.215MM; (42) REF BH206R, Heiss Delicate Forceps STR 200MM; (43) REF BH207R, Heiss Delicate Forceps CVD 200MM; (44) REF BH210R, Halsted-Mosquito Forceps DELSTR200MM; (45) REF BH211R, Halsted-Mosquito FCPS Del CVD 200MM; (46) REF BH212R, Halsted-Mosquito FCPSDELSTR1X2185MM; (47) REF BH213R, Halsted-Mosquito FCPSDELCVD1X2185MM; (48) REF BH214R, Halsted-Mosq.FCPSDELSTR1X2 200MM; (49) REF BH215R, Halsted-Mosq.FCPSDELCVD 1X2 200MM; (50) REF BH224R, Sarot Delicate Forceps 240MM; (51) REF BH225R, Crafoord Delicate Forceps CVD 245MM; (52) REF BH227R, Artery Forceps Crafoord MODIF.240MM; (53) REF BH228R, Bengolea Delicate Forceps STR 245MM; (54) REF BH229R, Bengolea Delicate Forceps CVD 245MM; (55) REF BH230R, Bridge Delicate Forceps STR 275MM; (56) REF BH231R, Bridge Delicate Forceps CVD 275MM; (57) REF BH234R, Sarot Delicate Forceps STR 1X2240MM; (58) REF BH316R, Pean Artery Forceps STR.165MM; (59) REF BH332R, Spencer-Wells Forceps STR130MM; (60) REF BH333R, Spencer-Wells Forceps CVD 130MM; continued

Aesculap

Class I - Dangerous

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Jan 31, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A

Intuitive Surgical

Class I - Dangerous

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Feb 26, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

COR Disposable Kit, 8 mm. Cartilage Transplant System.

DePuy Mitek, Inc., a Johnson & Johnson

Class I - Dangerous

Device is missing the pin in the graft loader component.

Feb 24, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.

Aesculap

Class I - Dangerous

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Jan 31, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

DePuy Mitek, Inc., a Johnson & Johnson

Class I - Dangerous

Device is missing the pin in the graft loader component.

Feb 24, 2025 Other Medical Devices Nationwide View Details →

GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

GE Medical Systems

Class I - Dangerous

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Feb 18, 2025 Other Medical Devices View Details →

Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, Fuchsig Artery Forceps CVD.190MM; (2) REF BH304R, Pean Artery Forceps Straight 140MM; (3) REF BH813R, Artery Forceps Curved 250MM; (4) REF BJ016R, Diss.A.Ligat.Forceps S-Shaped CVD.210MM; (5) REF BJ020R, Overholt-Geiss Suture FCPS #0CVD195MM; (6) REF BJ021R, Overholt-Geiss Suture FCPS #1CVD205MM; (7) REF BJ022R, Overholt-Geiss Suture FCPS #2CVD220MM; (8) REF BJ023R, Overholt-Geiss Suture FCPS #3 CVD225MM; (9) REF BJ025R, Overholt-Geiss Suture FCPS #5CVD230MM; (10) REF BJ026R, Overholt-Geiss Suture FCPS #6 CVD225MM; (11) REF BJ031R, Overholt-Geiss Suture FCPS#1CVD260MM; (12) REF BJ034R, Overholt-Geiss Suture FCPS#4CVD270MM; (13) REF BJ035R, Overholt-Geiss Suture FCPS #5CVD280MM; (14) REF BJ037R, Forceps CVD Delicate 145MM; (15) REF BJ038R, Forceps CVD.Delicate 185MM; (16) REF BJ039R, Forceps CVD.Delicate 235MM; (17) REF BJ041R, Rumel Suture Forceps SLT-CVD 240MM; (18) REF BJ042R, Rumel Suture Forceps CVD 240MM; (19) REF BJ043R, Rumel Suture Forceps MED-CV 240MM; (20) REF BJ044R, Rumel Suture Forceps HVY-CV 240MM; (21) REF BJ045R, Rumel Suture Forceps RT-ANG# 5 240MM; (22) REF BJ047R, Zenker Suture Forceps SLT-CVD 300MM; (23) REF BJ048R, Zenker Suture Forceps HVY-CVD 290MM; (24) REF BJ050R, Mixter-O'Shaugnessy Forceps CVD190MM; (25) REF BJ051R, Wikstroem Suture Forceps RT-ANG 205MM; (26) REF BJ052R, Finochietto Suture FCPCVDW/HOLE245MM; (27) REF BJ055R, Mixter Suture Forceps Rt-Ang 230MM; (28) REF BJ057R, Kantrowitz Thoracic Clamp 200MM; (29) REF BJ058R, Kantrowitz Thoracic Clamp 245MM; (30) REF BJ059R, Kantrowitz Thoracic Clamp 275MM; (31) REF BJ060R, Lahey Forceps Long-Serr 225MM; (32) REF BJ061R, Mixter Forceps Long-Serr220MM; (33) REF BJ062R, Mixter Forceps Long-Serr 250MM; (34) REF BJ068R, Lahey DISS.A.LIGAT.FORCEPS 230MM; (35) REF BJ070R, Lawrence Suture FCPS DEL CVDD 270MM; (36) REF BJ073R, Mixter Forceps Long-Serr 290MM; (37) REF BJ080R, Overholt Forceps # 0 CVD215MM; (38) REF BJ081R, Overholt Forceps # 1 CVD210MM; (39) REF BJ082R, Overholt Forceps # 2 CVD 220MM; (40) REF BJ083R, Overholt Forceps # 3 CVD 225MM; (41) REF BJ086R, Overholt Forceps # 6 CVD 225MM; (42) REF BJ090R, Overholt Forceps # 0 CVD 295MM; (43) REF BJ091R, Overholt Forceps # 1 CVD 295MM; (44) REF BJ096R, Overholt Forceps # 6 CVD 300MM; (45) REF BJ100R, Gemini Clamp RT-ANG140MM; (46) REF BJ102R, Gemini Clamp RT-ANG 180MM; (47) REF BJ103R, Gemini Clamp RT-ANG 200MM; (48) REF BJ104R, Gemini Clamp RT-ANG 230MM; (49) REF BJ106R, Gemini Clamp RT-ANG 280MM; (50) REF BJ120R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 160MM; (51) REF BJ121R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 180MM; (52) REF BJ122R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 200MM; (53) REF BJ123R, O'Shaugnessy DISS.A.LIGAT.FORCEPS 220MM; (54) REF BJ130R, Zenker DISS & LIG FCPSSLT-CVD 350MM; (55) REF BJ131R, Zenker DISS & LIG FCPS CVD 350MM; continued

Aesculap

Class I - Dangerous

The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

Jan 31, 2025 Other Medical Devices Nationwide View Details →

AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80

Integra LifeSciences

Class I - Dangerous

Possibility for the obturator to break (separate).

Feb 6, 2025 Other Medical Devices Nationwide View Details →

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

Micro Therapeutics

Class I - Dangerous

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

Jan 30, 2025 Other Medical Devices Nationwide View Details →

BD BBL TB Stain Kit K, Catalog (REF): 212522

Becton Dickinson &

Class I - Dangerous

One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.

Feb 12, 2025 Other Medical Devices View Details →

CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

Kung Shin Plastics Co.

Class I - Dangerous

The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.

Jan 9, 2025 Other Medical Devices Nationwide View Details →

Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availability. Under conditions of hypoxia, the level of EPO in the circulation increases and this leads to increased production of red blood cells.

Beckman Coulter

Class I - Dangerous

Affected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested with the affected lot may demonstrate repeatable falsely decreased results, which may lead to improper diagnosis or repeat testing.

Feb 3, 2025 Other Medical Devices Nationwide View Details →