États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
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 FoodJUICE from the Raw, pineapple mint
JUICE from the Raw, pineapple mint
Under-processed product may contain pathogenic bacteria that could harm to humans.
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 Model/Catalog Number: KD-V411M-0725; 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-0725; 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-VC431Q-0730; 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-VC431Q-0730; 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 Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-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 DevicesHOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
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 Devices*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
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 DevicesThe Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
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 FoodCINNAMON POWDER NET WT : 3.5 oz (100g) PRODUCT OF INDIA UPC 7 46241 29537 8 Distributed by: Venzu Traders LLC venzutraders@outlook.com
CINNAMON POWDER NET WT : 3.5 oz (100g) PRODUCT OF INDIA UPC 7 46241 29537 8 Distributed by: Venzu Traders LLC venzutraders@outlook.com
Potential contamination with heavy metal (lead).
FDA FoodBarbaCuban Havana Gold, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles. UPC code 7 19660 00097 7
BarbaCuban Havana Gold, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles. UPC code 7 19660 00097 7
Undeclared Quinine
FDA FoodBarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Kehe Case Code 1 99284 27227 9
BarbaCuban 455 Everything Sauce (Original), Net Wt 12 oz (355 ml) glass bottle and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. Refrigerate after opening. UPC Code 7 19660 00091 5, Kehe Case Code 1 99284 27227 9
Undeclared Quinine
USDA FSISCS Beef Packers, LLC Recalls Ground Beef Products That May be Contaminated With E. Coli O145
CS Beef Packers, LLC Recalls Ground Beef Products That May be Contaminated With E. Coli O145
Product Contamination
FDA DevicesVITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o Imipenem (ipm05n) o Imipenem/Relebactam (ipr01n); CARD NAME/ PRODUCT REFERENCE: AST-N399 423701 AST-N402 423644 AST-N403 423645 AST-N404 423664 AST-N405 423864 AST-N406 423869 AST-N407 423870 AST-N409 423925 AST-N412 423936 AST-N413 423928 AST-N414 423933 AST-N415 423934 AST-N416 423935 AST-N417 423880 AST-N419 423948 AST-N421 424055 AST-N428 424320 AST-N429 424321 AST-N430 424322 AST-N433 424389 AST-N439 424501 AST-N440 424502 AST-N443 424541 AST-N444 424587 AST-N467 424857 AST-N476 424934 AST-N478 425052 AST-N480 425084 AST-N481 425085 AST-N485 425182 AST-N496 425265 AST-N800 423310 AST-N802 423706 AST-N804 424634 AST-N808 424711 AST-N810 424712 AST-N811 424713 AST-N813 424722 AST-N815 425054 AST-XN09 423425 AST-XN15 423829 AST-XN17 423673 AST-XN18 423874 AST-XN20 423947 AST-XN21 424197 AST-XN22 424199 AST-XN23 424198 AST-XN24 424351 AST-XN26 424500 AST-XN28 424586 AST-XN29 424604 AST-XN30 424639 AST-XN31 424640 AST-XN32 424678 AST-XN33 424723 AST-XN34 424752 AST-XN35 424810 AST-XN36 424860 AST-XN37 424888 AST-XN38 425074 AST-XN39 425086 AST-XN40 425095 AST-XN41 425204 AST-XN42 425309 ***Update 4/2/26 -- Additional product references not manufactured at time of initial notification. These products will not be distributed within the United States.*** AST-N484 Ref. 425181 AST-N486 Ref. 425183 AST-N491 Ref. 425206 AST-N494 Ref. 425224 AST-N485 Ref. 425182 AST-XN41 Ref. 425204 AST-XN42 Ref. 425309 AST-N504 Ref. 425491
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
FDA DevicesConvenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
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 DrugsTrazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Presence of Foreign Tablets/Capsules
FDA DevicesAXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
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 DrugsBisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
FDA DevicesPRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX HF1000 SET, Product Code 107142; 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 FoodOrganic Chia Seed Black Origin: PARAGUAY Net weight: 55.12 LBS Produced for: Tradin Organics USA, LLC, Aptos
Organic Chia Seed Black Origin: PARAGUAY Net weight: 55.12 LBS Produced for: Tradin Organics USA, LLC, Aptos
Potential contamination with Salmonella.
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 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 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 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)