Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
NHTSAZoox, Inc. - ADS Software May Fail to Detect and Respond to Heavy Smoke
Zoox, Inc. - ADS Software May Fail to Detect and Respond to Heavy Smoke
Failing to respond to low visibility conditions can increase the risk of a crash or impede first responders.
CPSCBest Buy Recalls Insignia® Gas Ranges Due to Risk of Serious Injury from a Fire Hazard
Best Buy Recalls Insignia® Gas Ranges Due to Risk of Serious Injury from a Fire Hazard
The recalled ranges' front-mounted knobs can be activated accidentally by humans or pets, posing a risk of serious injury from a fire hazard.
CPSCFlaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards
Flaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire and Burn Hazards
The lithium-ion battery in the recalled power banks (chargers) can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
CPSCGreenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard
Greenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to Risk of Serious Injury from Fire Hazard
Charging the lithium-ion batteries through the USB-C port, while the batteries are inserted in the yard power tools can cause the batteries to short-circuit, posing a risk of serious injury from fire hazard.
NHTSAVolvo Trucks North America - Loss of Steering Control from Loose Steering Arm Fasteners
Volvo Trucks North America - Loss of Steering Control from Loose Steering Arm Fasteners
A loose steering arm can result in a loss of vehicle steering control, increasing the risk of a crash.
CPSCConair Recalls Cuisinart Propel+ Four Burner 3-In-1 Gas Grills Due to Risk of Serious Injury from Laceration Hazard
Conair Recalls Cuisinart Propel+ Four Burner 3-In-1 Gas Grills Due to Risk of Serious Injury from Laceration Hazard
The tempered glass window in the pizza oven can shatter during use, posing a risk of serious injury from laceration hazard.
CPSCWonderStone Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers; Sold on Walmart.com by Wonder Stone Toys
WonderStone Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall Hazard; Violate Mandatory Standard for Infant Walkers; Sold on Walmart.com by Wonder Stone Toys
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a risk of serious injury or death due to a fall hazard.
CPSCMoodooy Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Yuezhang
Moodooy Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Yuezhang
The recalled bed rails violate the mandatory standard for?adult portable bed rails?because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation.?In addition, the bed rails do not bear the required hazard warning labels.
CPSCBiometric Gun Safes Recalled Due to Serious Injury Hazard and Risk of Death; Sold Exclusively on Amazon.com by BBRKIN
Biometric Gun Safes Recalled Due to Serious Injury Hazard and Risk of Death; Sold Exclusively on Amazon.com by BBRKIN
The biometric lock on the gun safes can be opened by unauthorized users, posing a serious injury hazard and risk of death.
FDA DrugsBD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
FDA DevicesHillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
FDA DevicesMedline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290; 12) AVA HIGH FLOW, Model Number: ECVC3720; 13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215; 14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080; 15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; 16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505; 17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02; 18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA; 20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US; 21) CVC BUNDLE, Model Number: ECVC8090; 22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885; 23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845; 26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; 27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 28) CVC INSERTION BUNDLE, Model Number: ECVC1120; 29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075; 32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745; 33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945; 34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 6) CVC Insertion Bundle 3L 7FR 20CM, Model Number: ECVC5610; 7) TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3810; 8) 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; 9) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750; 10) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 11) TRIPLE LUMEN CVC 20CM BUNDLE W/O SUTURE, Model Number: ECVC7290; 12) AVA HIGH FLOW, Model Number: ECVC3720; 13) 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC8215; 14) CENTRAL LINE INSERTION BUNDLE, Model Number: ECVC2080; 15) 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; 16) VANTEX 7FR 3L 20CM CVC BUNDLE, Model Number: ECVC6505; 17) VANTEX 7FR, 16CM, 3L CVC BUNDLE, Model Number: STCVC02; 18) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 19) INTROFLEX 8.5FR. 1L CVC BUNDLE, Model Number: CMPI851LBA; 20) INTROFLEX 5F, 1L, TB, US, BAS, Model Number: STCVC49US; 21) CVC BUNDLE, Model Number: ECVC8090; 22) TRIPLE LUMEN INSERTION KIT W/CATHETER, Model Number: ECVC2885; 23) O.R. CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC1377; 24) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 25) 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC6845; 26) CVC BUNDLE TRIPLE LUMEN 16CM, Model Number: ECVC5540A; 27) CDP, MM, 3L, 7F, 16CM, H, Model Number: 3K16H1838; 28) CVC INSERTION BUNDLE, Model Number: ECVC1120; 29) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 30) TRIPLE LUMEN COMPLETE CATH KIT, Model Number: ECVC5200; 31) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC8075; 32) CENTRAL LINE BUNDLE W/7F, 16CM, 3L, Model Number: ECVC2745; 33) VANTEX 7FR 3L 16CM CVC BUNDLE W/US, Model Number: ECVC7945; 34) CENTRAL LINE BUNDLE W/7F, 20CM, 3L, Model Number: ECVC2750
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA DevicesIntelliCuff, Portable automatic cuff pressure controller REF: 951001
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
FDA DrugsAccucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01.
Lack of Assurance of Sterility
FDA DevicesMedline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
FDA DevicesMedline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: PAIN1967A; 6) TRAY,CON EPID,19G REINF OPNTIP, Model Number: PAIN2269; 7) EPIDURAL TRAY, Model Number: PAIN2278; 8) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN2305; 9) CSE TRAY MEDLINE, Model Number: PAIN2334; 10) PNBT TRAY, Model Number: SAMPA0147
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA DevicesMedline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
FDA DevicesRayCare 2024A SP4. Oncology Information Systems.
RayCare 2024A SP4. Oncology Information Systems.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
FDA DevicesCRE Wireguided 6-8mm 240cm
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
FDA DevicesARTIS icono ceiling. Model Number: 11328100.
ARTIS icono ceiling. Model Number: 11328100.
Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
FDA DevicesRadius VSM Disposable NIBP Cuff, REF: 4825, 4826
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.
FDA DevicesCRE Pro Wireguided 10-12mm 240cm
CRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
NHTSABMW of North America, LLC - Starter Motor May Overheat and Cause a Fire
BMW of North America, LLC - Starter Motor May Overheat and Cause a Fire
Fire increases the risk of injury.
FDA DevicesShort Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.