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FDA DevicesCLARITY II Laser System; Model No. 1110200210.
CLARITY II Laser System; Model No. 1110200210.
Reports of devices sparking/popping and potentially burning patients.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 860010-1L
Penner Pacific Bathing Spa, Model Numbers 860010-1L
The device does not bear a unique device identifier.
FDA DevicesGEM Premier 5000; Part No. 00055445008.
GEM Premier 5000; Part No. 00055445008.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA FoodSecondary Packaging: STEAM NOODLES INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVEM F.D. & C. YELLOW COLOR #5 & #6 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. STEAM NOODLE NET WEIGHT 10 LBS. (4536 grams) PERISHABLE KEEP REFRIGERATED INGREDIENTS: ENRICHED WHEAT FLOUR (BLEACHED WHEAT FLOUR, NIACIN, IRON, ASCORBIC ACID, THIAMIN MONONITRATE, RIBOFLAVIN), WATER, SALT, SOYBEAN OIL, SODIUM BI-CARBONATE, 1/1000 BENZOATE OF SODIUM, DUSTED WITH CORN STARCH, ADDED AS A PRESERVATIVE, F.D. & C. YELLOW COLOR #5 AND #6 (TARTRAZINE) (ARTIFICIAL COLORS). ALLERGY INFORMATION: WHEAT
Secondary Packaging: STEAM NOODLES INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE OF SODA ADDED AS PRESERVATIVEM F.D. & C. YELLOW COLOR #5 & #6 (TARTRAZINE) ARTIFICIAL COLORS) Primary Packaging: CHINA NOODLE CO. STEAM NOODLE NET WEIGHT 10 LBS. (4536 grams) PERISHABLE KEEP REFRIGERATED INGREDIENTS: ENRICHED WHEAT FLOUR (BLEACHED WHEAT FLOUR, NIACIN, IRON, ASCORBIC ACID, THIAMIN MONONITRATE, RIBOFLAVIN), WATER, SALT, SOYBEAN OIL, SODIUM BI-CARBONATE, 1/1000 BENZOATE OF SODIUM, DUSTED WITH CORN STARCH, ADDED AS A PRESERVATIVE, F.D. & C. YELLOW COLOR #5 AND #6 (TARTRAZINE) (ARTIFICIAL COLORS). ALLERGY INFORMATION: WHEAT
Undeclared wheat.
FDA DevicesGEM Premier 5000 PAK; Part No. 00055415004.
GEM Premier 5000 PAK; Part No. 00055415004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA FoodLowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case
Lowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case
Inaccurate nutritional data in Nutrition Facts including but not limited to, understated sodium content. Undeclared ingredients including but not limited to, monosodium glutamate.
NHTSAKeystone RV Company - Improperly Secured Wiring May Be Damaged
Keystone RV Company - Improperly Secured Wiring May Be Damaged
Damaged wiring may cause an electrical fault, increasing the risk of a fire.
NHTSAToyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
Toyota Motor Engineering & Manufacturing - Rearview Camera Image May Not Display/FMVSS 111
A rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
FDA DevicesGEM Premier 5000 PAK, Part No. 00055360004.
GEM Premier 5000 PAK, Part No. 00055360004.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA DevicesEndo-Model Replacement Plateau; Item Number: 15-2835/12;
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA DevicesPenner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
The device does not bear a unique device identifier.
FDA DevicesEndo-Model Replacement Plateau; Item Number: 15-0027/16;
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA FoodCoco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt. 19 oz. (510g), Keep Frozen, packaged in a microwaveable plastic container, UPC 0680334993607
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo in homemade Alfredo Sauce, Net Wt. 19 oz. (510g), Keep Frozen, packaged in a microwaveable plastic container, UPC 0680334993607
Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheat
FDA FoodFrozen Raw Bulk 9 inch Blueberry Crumble Pie ES (4 pies/case). Net wt. 38oz. UPC 00022518893257. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are intended to be baked by the retailer before consumer sale. Frozen raw pies were not sold to consumers at retail stores. Product is labeled with BAKING INSTRUCTIONS: Preheat convection oven to 340 degrees Fahrenheit. Bake pies for 70-80 minutes. Ovens will vary. Adjust time and temperature accordingly to ensure center of pie reaches 210F.
Frozen Raw Bulk 9 inch Blueberry Crumble Pie ES (4 pies/case). Net wt. 38oz. UPC 00022518893257. Handmade - Willamette Valley Pie Company LLC. 1651 Eska Way, Silverton, OR. Frozen raw pies were sold frozen in bulk packaging to grocery retailers' in-store bakeries. They are intended to be baked by the retailer before consumer sale. Frozen raw pies were not sold to consumers at retail stores. Product is labeled with BAKING INSTRUCTIONS: Preheat convection oven to 340 degrees Fahrenheit. Bake pies for 70-80 minutes. Ovens will vary. Adjust time and temperature accordingly to ensure center of pie reaches 210F.
Potential contamination with listeria monocytogenes.
FDA DrugsIcosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
FDA DevicesEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
FDA DevicesGEM Premier 5000; Part No. 00055430011.
GEM Premier 5000; Part No. 00055430011.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA DevicesArtelon FlexBand Plus Ref: 41054 & 41057
Artelon FlexBand Plus Ref: 41054 & 41057
Augmentation devices failed bacterial endotoxin testing.
FDA DevicesPHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Number: 11101-000017 UDI-DI code: 00721902682483 Infant/Child Reduced Energy Defibrillation Electrodes are pre gelled, self-adhesive, therapy electrodes that allow hands free defibrillation. These electrodes reduce the energy delivered to the patient by a factor of 4:1. The Infant/child reduced energy defibrillation electrodes are therapy electrodes designed to allow personnel who are trained on AED device operation and in basic life support, or other physician authorized emergency medical response systems, to safely and effectively defibrillate infants and children who are less than 8 years old or weigh less than 25kg (55lbs).
Due to pediatric defibrillator electrode delamination
FDA DevicesGEM Premier 5000 PAK; Part No. 00055407510.
GEM Premier 5000 PAK; Part No. 00055407510.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA DevicesGEM Premier 5000 PAK; Part No. 00055407508.
GEM Premier 5000 PAK; Part No. 00055407508.
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.
FDA FoodMade Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Garlic & Herb Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.
FDA DevicesCHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment
FDA FoodMade Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub
Made Fresh Salads brand Scallion Cream Cheese; 5 lb white plastic tub
Products may be contaminated with Listeria monocytogenes.