Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm anticipated.
Sliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste; Keep Frozen; Net WT: 12.2OZ (374g); UPC: 6 78108 16991 4
Sliced Korean Halibut with Soy sauce, Wasabi, Vinegar Chili Paste; Keep Frozen; Net WT: 12.2OZ (374g); UPC: 6 78108 16991 4
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Clover Hill Dairy LLP, Flavored Cheese (Old Bay Cheddar). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Flavored Cheese (Old Bay Cheddar). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
Volvo Trucks North America - Marker Lights May Fail to Illuminate/FMVSS 108
Volvo Trucks North America - Marker Lights May Fail to Illuminate/FMVSS 108
Marker lights that fail to illuminate can reduce visibility, increasing the risk of a crash.
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Potential for breach in sterile barrier of device packaging.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
Big Way Hot Pot "Hot Pot Miso Paste"; 1kg (35.3oz) unit package. Product is packaged in generic bulk packaging.
Undeclared milk from lactose.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number: 722059. 12. Allura Xper FD20/20; Model Number: 722038. 13. Allura Xper FD20/20 OR Table; Model Number: 722039. 14. Allura Xper R9 7 M12; Model Number: 722065. 15. Allura Xper R9 7 M20; Model Number: 722066. Interventional Fluoroscopic X-Ray System.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Manifolds. SAMMC ANGIOGRAPHY SAMM066-15
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifolds. Particulate within the fluid path has the potential to be introduced into blood circulation and become lodged within blood vessels.
Clover Hill Dairy LLP, sharp cheese variety (Cheddar, Yummy Cheddar, White Cheddar, Monterey Jack). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, and 5-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, sharp cheese variety (Cheddar, Yummy Cheddar, White Cheddar, Monterey Jack). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, and 5-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 809897 940169
Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz. Korean Traditional Premium Soybean Paste UPC: 8 809897 940169
Product label allergen "contains" statement does not include anchovy(fish)
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
shortfill; reports of empty capsules.
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases. Component: No.
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Clover Hill Dairy LLP, Flavored Cheese (horseradish). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Flavored Cheese (horseradish). Sold in approximate 1/2-lb, 1-lb, 2.5-lb, 5-lb, and 40-lb units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
Clover Hill Dairy LLP, Soft Cuajada crumbs. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, Soft Cuajada crumbs. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.
La Colonia Foods Salvadoreno Requeson Soft Ricotta, Net Wt: 14 oz (367g), packaged into retail-sized clear plastic containers. Keep refrigerated.
La Colonia Foods Salvadoreno Requeson Soft Ricotta, Net Wt: 14 oz (367g), packaged into retail-sized clear plastic containers. Keep refrigerated.
Products may be contaminated with Listeria monocytogenes.
Requeson, bulk product from Clover Hill Dairy packed into a plastic 18-lb bucket. Unknown labeling information. Keep refrigerated.
Requeson, bulk product from Clover Hill Dairy packed into a plastic 18-lb bucket. Unknown labeling information. Keep refrigerated.
Products may be contaminated with Listeria monocytogenes.
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Presence of Particulate Matter; identified as stainless steel
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
Clover Hill Dairy LLP, mild cheese variety (Fresh Cheddar Curd). Sold in approximate 0.75-lb and 1.5-lb box units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Clover Hill Dairy LLP, mild cheese variety (Fresh Cheddar Curd). Sold in approximate 0.75-lb and 1.5-lb box units. Unknown information: packaging, labeling, or total quantity of product distributed. Keep refrigerated.
Product contaminated with Listeria monocytogenes.