November 15, 2024 The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about safety concerns with the use of Getinge/Maquet VasoView HemoPro Endoscopic Vessel Harvesting (EVH) Systems, and a supply concern for EVH devices. On September 20, 2024, Getinge/Maquet issued an Urgent Medical Device Removal notice to inform users to…
VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 06, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: VitalityVita Brand Name: Brand Name(s) VitalityVita Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, VitalityVita.com is…
Boulla LLC Issues Voluntary Nationwide Recall of ZoomMax and ZapMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac
Summary Company Announcement Date: November 04, 2024 FDA Publish Date: November 05, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Undeclared Sildenafil and Diclofenac Company Name: Boulla LLC Brand Name: Brand Name(s) Boulla LLC Product Description: Product Description Marketed as Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA,…
IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Phasitron 5 breathing circuits Part Numbers/Lot Numbers: P5-10/240329, 240412,240430, 240509, 240516, 240614, 240625 …
Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results
This recall involves updating recall instructions for using these devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. Affected Product…
Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
2082844-001-526493, 1TABX6226911180201 (TABX62269) 2082844-001-526493, 1TABX6215911180122 (TABX62159) 2082844-001-526493, 1TABX6219811180129 (TABX62198) 2082844-001-526493, 1TABX6227011180201 (TABX62270) 2082844-001-526493, 1TABX6229111180202 (TABX62291) 2082844-001-526493, 1TABX6215611180122 (TABX62156) 2082844-001-526493, 1TABX6226011180201 (TABX62260) 2082844-001-526493, 1TABX6213511180119 (TABX62135) 2082844-001-526493, 1TABX6218911180124 (TABX62189) 2082844-001-526493, 1TABX6219611180124 (TABX62196) 2082844-001-526493, 1TABX6218811180124 (TABX62188) 2082844-001-526493, 1TABX6216011180122 (TABX62160) 2082844-001-487119, To be provided (TABV60550) 2082844-001-526493, 1TABW6398711171213 (TABW63987) 2082844-001-526493, 1TABX6214111180119 (TABX62141) 2082844-001-526493, 1TABW6409911171219 (TABW64099) 2082844-001-526493, 1TABW6400911171213 (TABW64009) 2082844-001-526493, 1TABW6396611171211…
Update: Use of GE HealthCare EVair and EVair 03 Compressors – Letter to Health Care Providers
October 29, 2024 The U.S. Food and Drug Administration (FDA) is issuing this update to inform the health care community of a change in recommendations for the GE HealthCare EVair Compressor. Previously, on December 29, 2023, GE HealthCare issued an Urgent Medical Device Correction notice to inform users about the potential for elevated levels of…
Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction. Affected Product Product Names: Jaco Assistive Robotic Arm Models: …
Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication
Español 简体中文 (Simplified Chinese) Tagalog Date Issued: October 25, 2024 The U.S. Food and Drug Administration (FDA) is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers (hereafter referred to simply as BioZorb Markers) by Hologic Inc. On October 25, 2024, Hologic announced a voluntary recall…
Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX 101/800/060CZ 3895097392583540256004106716423014942525004382002 BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX 101/800/070CZ 3895101392596039330884010050402279040348264037975413361241524404156971421780442382374249341430594443059474368641 BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX 101/800/075CZ 3895100392574839330864025599403482540379744073768411792741348274152439415697042382344249234434889843488994365892 BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX 101/800/080CZ 3895103390967039330444037971405262141382254156969422469542300784232686424546942474074270931429119043059334305934430593543059364305938 BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX 101/800/085CZ 39220273951221403482442563834348861 BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX 101/800/090CZ 3895099395122039684064039797419702542178034238236426164842732314306047431043943766124387369 BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX 101/800/100CZ 389511039512194000129423007643060584372161438660043907444413606 BLUSELECT 6.0, CUFFED, FEN, 10/BX 101/802/060CZ…