États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
FDA DevicesOrthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
FDA FoodIce Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 710594511362
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA FoodIce Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487
Ice Pop, D'Dioses Pistachio, 1 Bar (81.7 g), with UPC 827912008487
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA DevicesT-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA DevicesABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FDA DevicesAbiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
FDA DevicesThe Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
FDA DevicesABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FDA DevicesABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FDA DrugsAUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
FDA DevicesABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FDA DevicesTransvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA DevicesPapablic Replacement Brush Heads. Model Number: PAPA317AA.
Papablic Replacement Brush Heads. Model Number: PAPA317AA.
Potential for brush heads to break.
FDA DevicesPapablic Replacement Brush Heads. Model Number: Papablic18B
Papablic Replacement Brush Heads. Model Number: Papablic18B
Potential for brush heads to break.
FDA DevicesOptima XR240amx, Mobile Digital Radiographic System
Optima XR240amx, Mobile Digital Radiographic System
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.
FDA FoodIce Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449
Ice Pop, D'Dioses Nanche, 1 Bar (81.7 g), with UPC 827912008449
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA FoodAmy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes. Let sit 1 minute. Stir. Serve. Stovetop: Heat soup in a saucepan, stirring occasionally. AMY'S KITCHEN, INC. P.O. BOX 7129 PETALUMA, CA 94955 UPC (for U.S. product): 042272005833 UPC (for Canada product): 10042272905833
Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM NET WT. 14.5 OZ. (411 g) Microwave: Place soup in a microwave-safe bowl. Cover. Cook for 1.5-2 minutes. Let sit 1 minute. Stir. Serve. Stovetop: Heat soup in a saucepan, stirring occasionally. AMY'S KITCHEN, INC. P.O. BOX 7129 PETALUMA, CA 94955 UPC (for U.S. product): 042272005833 UPC (for Canada product): 10042272905833
Potential for spoilage.
FDA DevicesGeneral Biospy Tray, REF: GUTS1000
General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA DevicesST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
FDA DevicesMedtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass vascular cannula
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
FDA FoodIce Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
Ice Pop, D'Dioses Mamey, 1 Bar (81.7 g), with UPC 827912008456
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
FDA DevicesOlympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
FDA Devicesda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
FDA DrugsGOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).