Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
NHTSADaimler Trucks North America, LLC - Improper Battery Connection May Cause Fire
Daimler Trucks North America, LLC - Improper Battery Connection May Cause Fire
A short circuit increases the risk of a fire.
FDA DevicesRumex Disposable Diamond Dusted ILM Elevator, 12-7523
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA DevicesS. Typhi/Para Typhi A Antigen
S. Typhi/Para Typhi A Antigen
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
FDA DevicesBrand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA DevicesProduct Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma Calibrator CAL 4 5.000 pg/mL pTau 217 Plasma Calibrator CAL 5 10.000 pg/mL pTau 217 Plasma Calibrator Contains Tris buffer with protein (bovine) and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950 Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
FDA FoodRepackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Public Policy, 6. Liberty University Environmental Health & Safety, 7. Subaru, 8. Trinity Cyb3r, 9. Candy Treats, 10. JSE, Jordan & Skala Engineers, 11. Dropbox DocSend, 12. PP, Prosperity Promotions, 13. Northwest Indian College Foundation, 14. FES Branding Solutions, 15. Berkshire Hathaway Guard Insurance Companies, 16. merry maids Annual 26 Conference, 17. BW, Best Western, 18. Morgan Stanley, 19. tufin, 20. Compliments of Pioneer, 21. A.D. Morgan, Construction Manager, Design Builder, General Contractor, 22. Adobe, 23. xfinity, 24. Fundermax Interiors, 25. White Cup, 26. Acadia Commercial, 27. Aviagen, 28. ORG Expo, 29. Make Your Mark For nutrition facts, information, and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Repackaged M&Ms candies, Net Wt 1.3 oz. Item BB458BG. Labeled with the following promotional company names. 1. Next Up, 2. Smith Pro, 3. Jaxport, Jacksonville Port Authority, 4. Climax Molybdenum, A Freeport-McMoRan Company, 5. University of Maryland, School of Public Policy, 6. Liberty University Environmental Health & Safety, 7. Subaru, 8. Trinity Cyb3r, 9. Candy Treats, 10. JSE, Jordan & Skala Engineers, 11. Dropbox DocSend, 12. PP, Prosperity Promotions, 13. Northwest Indian College Foundation, 14. FES Branding Solutions, 15. Berkshire Hathaway Guard Insurance Companies, 16. merry maids Annual 26 Conference, 17. BW, Best Western, 18. Morgan Stanley, 19. tufin, 20. Compliments of Pioneer, 21. A.D. Morgan, Construction Manager, Design Builder, General Contractor, 22. Adobe, 23. xfinity, 24. Fundermax Interiors, 25. White Cup, 26. Acadia Commercial, 27. Aviagen, 28. ORG Expo, 29. Make Your Mark For nutrition facts, information, and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
FDA DevicesCellMek SPS Sample Preparation System, REF: C44603, with software
CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
potential Clostridium botulinum contamination
FDA Devices25GA Subretinal Injection Cannula VS0220.25
25GA Subretinal Injection Cannula VS0220.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA FoodProduct is Frozen Half Shell Oysters in 15-16 pound blocks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side panel reads: Method of harvest: Farm Raised Country of Origin: Republic of Korea UPC: 850040844054
Product is Frozen Half Shell Oysters in 15-16 pound blocks. Packaged in generic brown cardboard boxes. Side panel reads: HAFL SHELL OYSTER Spec: 144PCS; Imported by: Khee Trading Inc., Compton, CA Side panel reads: Method of harvest: Farm Raised Country of Origin: Republic of Korea UPC: 850040844054
Imported oysters potentially contaminated with Norovirus
FDA DevicesAXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
FDA FoodBread Crumbs, Outside The Breadbox brand, net wt. 8 oz, UPC 873799001554. Product is packaged in a clear stand up pouch. Intended use baking. Condition/Shelf Life shelf stable, 180 days. Firm name Outside The Breadbox, 2027 W Colorado Ave. Colorado Springs, CO.
Bread Crumbs, Outside The Breadbox brand, net wt. 8 oz, UPC 873799001554. Product is packaged in a clear stand up pouch. Intended use baking. Condition/Shelf Life shelf stable, 180 days. Firm name Outside The Breadbox, 2027 W Colorado Ave. Colorado Springs, CO.
Undeclared allergens: egg and milk
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Elderberry- UPC# 5065006235189
potential Clostridium botulinum contamination
FDA DrugsRheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
CGMP Deviations: product found to contain lead.
FDA DevicesBrand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
FDA FoodImu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 00033 5 Firm name on label: Imu-Tek, 3541 East Vine Drive, Fort Collins, CO 80524
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7 38654 00033 5 Firm name on label: Imu-Tek, 3541 East Vine Drive, Fort Collins, CO 80524
Undeclared milk allergen
FDA DevicesVortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. 5 Blend in 1- UPC# 5061033690052
potential Clostridium botulinum contamination
FDA DevicesEMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
FDA DevicesPRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.