Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,563 results
Safety Alert
CPSC
CPSCSUNS International Recalls Residential Elevator Interlock Switches Due to Fall and Crushing Hazard; Risk of Death or Serious Injury
Unknown Firm
CPSCGeneral Alert
SUNS International Recalls Residential Elevator Interlock Switches Due to Fall and Crushing Hazard; Risk of Death or Serious Injury
The affected interlock switches can become stuck in a retracted position, allowing the exterior door to remain unlocked, posing a risk of death or serious injury if the elevator is called to another floor.
Jun 4, 2026
Safety AlertCPSC
CPSCPool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Broqixin
Unknown Firm
CPSCGeneral Alert
Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and Drowning Hazards; Violates Virginia Graeme Baker Pool & Spa Safety Act; Sold on Amazon by Broqixin
The recalled drain covers violate the entrapment protection standards of the?Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to swimmers and bathers.
Jun 4, 2026
Safety AlertCPSC
CPSCWyze Labs Recalls Solar Cam Pan Security Cameras Due to Risk of Serious Injury from Fire and Burn Hazards
Unknown Firm
CPSCGeneral Alert
Wyze Labs Recalls Solar Cam Pan Security Cameras Due to Risk of Serious Injury from Fire and Burn Hazards
The recalled Wyze Solar Cam Pan security cameras' incorrect assembly instructions can lead consumers to accidentally puncture the lithium?ion battery's metal casing, causing the battery to rapidly overheat, posing a risk of serious injury or property damage from fire and burn hazards.
Jun 4, 2026
Safety AlertCPSC
CPSCTiny Land Children's Play Tents Recalled Due to Risk of Injury from Irritation to Skin and Eyes
Unknown Firm
CPSCGeneral Alert
Tiny Land Children's Play Tents Recalled Due to Risk of Injury from Irritation to Skin and Eyes
The recalled tents' fiberglass poles can shed fibers, posing an injury risk of skin and eye irritation.
Jun 4, 2026
Vehicle RecallNHTSA
NHTSAAston Martin The Americas - Brake Master Cylinder Seal May Deform
Aston Martin The Americas
NHTSASERVICE BRAKES,...
Aston Martin The Americas - Brake Master Cylinder Seal May Deform
Brakes that overheat increase the risk of a fire.
Jun 3, 2026Aston Martin The Americas
Medical DeviceFDA Devices
FDA DevicesHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Devicor Medical Products Inc
FDA DevicesClass II
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Jun 3, 2026Devicor Medical Products Inc
Medical DeviceFDA Devices
FDA DevicesMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
Medtronic Neuromodulation
FDA DevicesClass II
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
Jun 3, 2026Medtronic Neuromodulation
Vehicle RecallNHTSA
NHTSAJayco, Inc. - False Taillight Warning Light on Instrument Panel Display/FMVSS 101
Jayco, Inc.
NHTSAELECTRICAL SYSTEM
Jayco, Inc. - False Taillight Warning Light on Instrument Panel Display/FMVSS 101
The incorrect warning light may fail to alert the driver to critical safety information or cause confusion, increasing the risk of a crash.
Jun 3, 2026Jayco, Inc.
PharmaceuticalFDA Drugs
FDA DrugsNicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
AVEVA Drug Delivery Systems, Inc.
FDA DrugsClass III
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Jun 3, 2026AVEVA Drug Delivery Systems, Inc.
Medical DeviceFDA Devices
FDA DevicesGE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies Inc
FDA DevicesClass II
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Jun 3, 2026GE Medical Systems Information Technologies Inc
Food & BeverageFDA Food
FDA FoodWawa Fruit Punch Pint (16oz), Plastic bottle
Wawa Beverage Company
FDA FoodClass I
Wawa Fruit Punch Pint (16oz), Plastic bottle
Undeclared Milk Allergen,
Jun 3, 2026Wawa Beverage Company
Medical DeviceFDA Devices
FDA DevicesHalyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
O&M HALYARD INC
FDA DevicesClass II
Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)
Nitrile Exam Glove failed to meet specifications chemical permeation performance.
Jun 3, 2026O&M HALYARD INC
Medical DeviceFDA Devices
FDA DevicesGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies Inc
FDA DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Jun 3, 2026GE Medical Systems Information Technologies Inc
Medical DeviceFDA Devices
FDA DevicesAzurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
Jun 3, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Food & BeverageFDA Food
FDA FoodWawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Wawa Beverage Company
FDA FoodClass I
Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle
Undeclared Milk Allergen,
Jun 3, 2026Wawa Beverage Company
Food & BeverageFDA Food
FDA FoodWawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Wawa Beverage Company
FDA FoodClass I
Wawa Diet Iced Tea Lemon Pint (16oz),Plastic bottle
Undeclared Milk Allergen,
Jun 3, 2026Wawa Beverage Company
Medical DeviceFDA Devices
FDA DevicesMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Medline Industries, LP
FDA DevicesClass I
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0245; 2) SPINAL TRAY W/PENCIL POINT NDL, Medline Kit SKU DYNJRA0555; 3) SPINAL TRAY, Medline Kit SKU DYNJRA0836A; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0978A; 5) TRAY, SPINAL, WHIT 24GX4, Medline Kit SKU DYNJRA1034; 6) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA9028; 7) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA9030.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Jun 3, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0255B; 5) SPINAL TRAY, Medline Kit SKU DYNJRA0320; 6) SPINAL TRAY, Medline Kit SKU DYNJRA0320A; 7) SPINAL BLOCK TRAY- LF, Medline Kit SKU DYNJRA0413C; 8) SPINAL TRAY, Medline Kit SKU DYNJRA0461D; 9) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA0945; 10) SPINAL TRAY, Medline Kit SKU DYNJRA1140B; 11) SPINAL TRAY, Medline Kit SKU DYNJRA1192; 12) SPINAL TRAY 25G, Medline Kit SKU DYNJRA1240; 13) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1288; 14) SPINAL 25G WHITACRE, Medline Kit SKU DYNJRA1301; 15) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1304; 16) AHN SPINAL TRAY, Medline Kit SKU DYNJRA1376; 17) SPINAL TRAY, Medline Kit SKU DYNJRA1477A; 18) ADULT SPINAL KIT, Medline Kit SKU DYNJRA1538; 19) SPINAL TRAY, Medline Kit SKU DYNJRA1558A; 20) SPINAL TRAY, Medline Kit SKU DYNJRA1560A; 21) SPINAL TRAY, Medline Kit SKU DYNJRA1565; 22) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA1577C; 23) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1584; 24) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA1740A; 25) SPINAL TRAY, Medline Kit SKU DYNJRA1744A; 26) SPINAL TRAY, Medline Kit SKU DYNJRA1750A; 27) SPINAL TRAY, Medline Kit SKU DYNJRA1784; 28) SPINAL TRAY, Medline Kit SKU DYNJRA1790; 29) SPINAL TRAY, Medline Kit SKU DYNJRA1796; 30) MSSC SPINAL TRAY, Medline Kit SKU DYNJRA1802B; 31) SPINAL TRAY, Medline Kit SKU DYNJRA1818; 32) SPINAL TRAY, Medline Kit SKU DYNJRA1839; 33) SPINAL TRAY, Medline Kit SKU DYNJRA1884; 34) SPINAL TRAY, Medline Kit SKU DYNJRA1884A; 35) 24G SPINAL KIT, Medline Kit SKU DYNJRA1889; 36) SPINAL TRAY, Medline Kit SKU DYNJRA1929; 37) SPINAL TRAY, Medline Kit SKU DYNJRA1969; 38) SPINAL TRAY, Medline Kit SKU DYNJRA1982; 39) SPINAL TRAY/PENCAN, Medline Kit SKU DYNJRA1983A; 40) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1987; 41) SPINAL TRAY - 3 ML CHLORAPREP, Medline Kit SKU DYNJRA2005; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2023; 43) SPINAL TRAY, Medline Kit SKU DYNJRA2068A; 44) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2088; 45) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA2115; 46) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2140; 48) SPINAL TRAY, Medline Kit SKU DYNJRA2153; 49) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA2213; 50) SPINAL TRAY, Medline Kit SKU DYNJRA2225; 51) OR SPINAL BLOCK KIT, Medline Kit SKU DYNJRA2349; 52) SPINAL TRAY, Medline Kit SKU DYNJRA2360; 53) L&D SPINAL TRAY, Medline Kit SKU DYNJRA2371; 54) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2381; 55) SPINAL TRAY, Medline Kit SKU DYNJRA2432A; 56) OB SPINAL TRAY, Medline Kit SKU DYNJRA2532; 57) SPINAL TRAY, Medline Kit SKU DYNJRA2534; 58) SPINAL TRAY, Medline Kit SKU DYNJRA2556; 59) SPINAL TRAY, Medline Kit SKU DYNJRA2566A; 60) SPINAL TRAY BRAUN, Medline Kit SKU DYNJRA2575; 61) SPINAL TRAY, Medline Kit SKU DYNJRA2592; 62) SPINAL TRAY, Medline Kit SKU DYNJRA2597; 63) SPINAL BLOCK, Medline Kit SKU DYNJRA2605; 64) SPINAL TRAY, Medline Kit SKU DYNJRA2606; 65) SPINAL TRAY, Medline Kit SKU DYNJRA2607; 66) SPINAL TRAY, Medline Kit SKU DYNJRA2607A; 67) SPINAL TRAY, Medline Kit SKU DYNJRA2611; 68) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2613; 69) SPINAL TRAY, Medline Kit SKU DYNJRA2618A; 70) SPINAL TRAY, Medline Kit SKU DYNJRA2634; 71) SPINAL TRAY, Medline Kit SKU DYNJRA2638; 72) SPINAL TRAY, Medline Kit SKU DYNJRA2639; 73) JOI SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2641; 74) SPINAL TRAY, Medline Kit SKU DYNJRA2653; 75) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2669; 76) SPINAL TRAY, Medline Kit SKU DYNJRA2670; 77) SPINAL BLOCK TRAY 18G INTRO, Medline Kit SKU DYNJRA2672; 78) SPINAL TRAY 24G, Medline Kit
Medline Industries, LP
FDA DevicesClass I
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL ANESTHESIA TRAY-LF, Medline Kit SKU DYNJRA0102A; 2) SPINAL TRAY-LF, Medline Kit SKU DYNJRA0143B; 3) SPINAL PREP TRAY-LF, Medline Kit SKU DYNJRA0205B; 4) SPINAL TRAY, Medline Kit SKU DYNJRA0255B; 5) SPINAL TRAY, Medline Kit SKU DYNJRA0320; 6) SPINAL TRAY, Medline Kit SKU DYNJRA0320A; 7) SPINAL BLOCK TRAY- LF, Medline Kit SKU DYNJRA0413C; 8) SPINAL TRAY, Medline Kit SKU DYNJRA0461D; 9) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA0945; 10) SPINAL TRAY, Medline Kit SKU DYNJRA1140B; 11) SPINAL TRAY, Medline Kit SKU DYNJRA1192; 12) SPINAL TRAY 25G, Medline Kit SKU DYNJRA1240; 13) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA1288; 14) SPINAL 25G WHITACRE, Medline Kit SKU DYNJRA1301; 15) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1304; 16) AHN SPINAL TRAY, Medline Kit SKU DYNJRA1376; 17) SPINAL TRAY, Medline Kit SKU DYNJRA1477A; 18) ADULT SPINAL KIT, Medline Kit SKU DYNJRA1538; 19) SPINAL TRAY, Medline Kit SKU DYNJRA1558A; 20) SPINAL TRAY, Medline Kit SKU DYNJRA1560A; 21) SPINAL TRAY, Medline Kit SKU DYNJRA1565; 22) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA1577C; 23) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1584; 24) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA1740A; 25) SPINAL TRAY, Medline Kit SKU DYNJRA1744A; 26) SPINAL TRAY, Medline Kit SKU DYNJRA1750A; 27) SPINAL TRAY, Medline Kit SKU DYNJRA1784; 28) SPINAL TRAY, Medline Kit SKU DYNJRA1790; 29) SPINAL TRAY, Medline Kit SKU DYNJRA1796; 30) MSSC SPINAL TRAY, Medline Kit SKU DYNJRA1802B; 31) SPINAL TRAY, Medline Kit SKU DYNJRA1818; 32) SPINAL TRAY, Medline Kit SKU DYNJRA1839; 33) SPINAL TRAY, Medline Kit SKU DYNJRA1884; 34) SPINAL TRAY, Medline Kit SKU DYNJRA1884A; 35) 24G SPINAL KIT, Medline Kit SKU DYNJRA1889; 36) SPINAL TRAY, Medline Kit SKU DYNJRA1929; 37) SPINAL TRAY, Medline Kit SKU DYNJRA1969; 38) SPINAL TRAY, Medline Kit SKU DYNJRA1982; 39) SPINAL TRAY/PENCAN, Medline Kit SKU DYNJRA1983A; 40) SPINAL NEEDLE TRAY, Medline Kit SKU DYNJRA1987; 41) SPINAL TRAY - 3 ML CHLORAPREP, Medline Kit SKU DYNJRA2005; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2023; 43) SPINAL TRAY, Medline Kit SKU DYNJRA2068A; 44) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2088; 45) 25G WHITACRE SPINAL TRAY, Medline Kit SKU DYNJRA2115; 46) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2140; 48) SPINAL TRAY, Medline Kit SKU DYNJRA2153; 49) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA2213; 50) SPINAL TRAY, Medline Kit SKU DYNJRA2225; 51) OR SPINAL BLOCK KIT, Medline Kit SKU DYNJRA2349; 52) SPINAL TRAY, Medline Kit SKU DYNJRA2360; 53) L&D SPINAL TRAY, Medline Kit SKU DYNJRA2371; 54) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2381; 55) SPINAL TRAY, Medline Kit SKU DYNJRA2432A; 56) OB SPINAL TRAY, Medline Kit SKU DYNJRA2532; 57) SPINAL TRAY, Medline Kit SKU DYNJRA2534; 58) SPINAL TRAY, Medline Kit SKU DYNJRA2556; 59) SPINAL TRAY, Medline Kit SKU DYNJRA2566A; 60) SPINAL TRAY BRAUN, Medline Kit SKU DYNJRA2575; 61) SPINAL TRAY, Medline Kit SKU DYNJRA2592; 62) SPINAL TRAY, Medline Kit SKU DYNJRA2597; 63) SPINAL BLOCK, Medline Kit SKU DYNJRA2605; 64) SPINAL TRAY, Medline Kit SKU DYNJRA2606; 65) SPINAL TRAY, Medline Kit SKU DYNJRA2607; 66) SPINAL TRAY, Medline Kit SKU DYNJRA2607A; 67) SPINAL TRAY, Medline Kit SKU DYNJRA2611; 68) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2613; 69) SPINAL TRAY, Medline Kit SKU DYNJRA2618A; 70) SPINAL TRAY, Medline Kit SKU DYNJRA2634; 71) SPINAL TRAY, Medline Kit SKU DYNJRA2638; 72) SPINAL TRAY, Medline Kit SKU DYNJRA2639; 73) JOI SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2641; 74) SPINAL TRAY, Medline Kit SKU DYNJRA2653; 75) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2669; 76) SPINAL TRAY, Medline Kit SKU DYNJRA2670; 77) SPINAL BLOCK TRAY 18G INTRO, Medline Kit SKU DYNJRA2672; 78) SPINAL TRAY 24G, Medline Kit
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Jun 3, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Medline Industries, LP
FDA DevicesClass II
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.
Jun 3, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Abiomed, Inc.
FDA DevicesClass I
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
Jun 3, 2026Abiomed, Inc.
Medical DeviceFDA Devices
FDA DevicesGE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE Medical Systems Information Technologies Inc
FDA DevicesClass II
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
Jun 3, 2026GE Medical Systems Information Technologies Inc
Medical DeviceFDA Devices
FDA DevicesMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.
Medline Industries, LP
FDA DevicesClass I
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN TRAY, Medline Kit SKU DYNJRA1555; 2) SPINAL BLOCK TRAY WHITACRE 24G, Medline Kit SKU DYNJRA1817; 3) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA1920; 4) ULTRASOUND GUIDED NERVE BLOCK, Medline Kit SKU DYNJRA2013; 5) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2017; 6) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067; 7) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2067A; 8) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2093; 9) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2117A; 10) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124; 11) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2124A; 12) PAIN TRAY, Medline Kit SKU DYNJRA2144; 13) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2221; 14) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2333; 15) SPINAL TRAY, Medline Kit SKU DYNJRA2390; 16) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKU DYNJRA2402; 17) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407; 18) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407A; 19) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2407B; 20) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447; 21) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2447A; 22) SPINAL TRAY 25G, Medline Kit SKU DYNJRA2488A; 23) J&S SPINAL TRAY, Medline Kit SKU DYNJRA2545; 24) SPINAL TRAY, Medline Kit SKU DYNJRA2549; 25) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2550; 26) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2552; 27) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554; 28) SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2554A; 29) SPINAL ANESTHESIA TRAY, Medline Kit SKU DYNJRA2578; 30) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2588; 31) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2602; 32) SPINAL TRAY, Medline Kit SKU DYNJRA2618; 33) SPINAL TRAY, Medline Kit SKU DYNJRA2619; 34) SPINAL TRAY, Medline Kit SKU DYNJRA2622; 35) SPINAL BLOCK 25 WHITACRE 5S ND, Medline Kit SKU DYNJRA2624; 36) SPINAL TRAY, Medline Kit SKU DYNJRA2631; 37) TRAY, SPINAL PENCIL POINT 25G, Medline Kit SKU DYNJRA2632; 38) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2633; 39) SPINAL TRAY, Medline Kit SKU DYNJRA2645; 40) TRAY, 25G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2654; 41) CSE PAIN MANAGEMENT TRAY, Medline Kit SKU DYNJRA2665; 42) SPINAL TRAY, Medline Kit SKU DYNJRA2667; 43) SPINAL TRAY 24G BD, Medline Kit SKU DYNJRA2675; 44) SPINAL TRAY W/ CHLORAPREP, Medline Kit SKU DYNJRA2680; 45) SPINAL TRAY, Medline Kit SKU DYNJRA2682; 46) TRAY, 24G WHIT SPINAL W/PHARM, Medline Kit SKU DYNJRA2684; 47) SPINAL TRAY, Medline Kit SKU DYNJRA2725; 48) 25G SPINAL BLOCK TRAY, Medline Kit SKU DYNJRA2757; 49) TRAY, 25G SPINAL W/RX DURAPREP, Medline Kit SKU DYNJRA9039; 50) TRAY, 25G SPINAL W/RX, Medline Kit SKU DYNJRA9045; 51) SLSYSTEM CSE TRAY, Medline Kit SKU PAIN2333; 52) 25G SPINAL BLOCK TRAY, Medline Kit SKU SAMPA0135.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Jun 3, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesRelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U
Bolton Medical Inc.
FDA DevicesClass I
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U 28-N4-36-154-36U 28-N4-36-199-32U 28-N4-36-199-36U 28-N4-36-259-36U 28-N4-38-109-38U 28-N4-38-154-34U 28-N4-38-154-38U 28-N4-38-199-34U 28-N4-38-199-38U 28-N4-38-259-38U 28-N4-40-114-40U 28-N4-40-154-36U 28-N4-40-154-40U 28-N4-40-204-36U 28-N4-40-204-40U 28-N4-40-259-40U 28-N4-42-114-42U 28-N4-42-159-38U 28-N4-42-159-42U 28-N4-42-204-38U 28-N4-42-204-42U 28-N4-42-259-42U 28-N4-44-114-44U 28-N4-44-164-40U 28-N4-44-164-44U 28-N4-44-209-40U 28-N4-44-209-44U 28-N4-44-259-40U 28-N4-44-259-44U 28-N4-46-114-46U 28-N4-46-164-42U 28-N4-46-164-46U 28-N4-46-209-42U 28-N4-46-209-46U 28-N4-46-259-42U
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
Jun 3, 2026Bolton Medical Inc.
Medical DeviceFDA Devices
FDA DevicesMedline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.
Medline Industries, LP
FDA DevicesClass I
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit SKU DYNJRA1181C; 2) SPINAL BLOCK 25G WHTCRE 5S BU, Medline Kit SKu DYNJRA1860.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Jun 3, 2026Medline Industries, LP