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Food & BeverageFranceRappelConso

veed - mondo gummies cbd

veed
RappelConsovolontaire (san...

veed - mondo gummies cbd

recommandation de consommation journalière conduisant a un dépassement de la dose de référence aiguë en delta 9 thc

Mar 18, 2026veed
Medical DeviceUSFDA Devices

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Waldemar Link GmbH & Co. KG (Mfg Site)
FDA DevicesClass II

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Mar 18, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Food & BeverageFranceRappelConso

vrac - cookie 30mg cbd

vrac
RappelConsovolontaire (san...

vrac - cookie 30mg cbd

recommandation de consommation journalière conduisant a un dépassement de la dose de référence aiguë en delta 9 thc

Mar 18, 2026vrac
Food & BeverageFranceRappelConso

vibes - cookie 150mg cbd

vibes
RappelConsovolontaire (san...

vibes - cookie 150mg cbd

recommandation de consommation journalière conduisant a un dépassement de la dose de référence aiguë en delta 9 thc

Mar 18, 2026vibes
Food & BeverageFranceRappelConso

acevia - fromage de tête

acevia
RappelConsovolontaire (san...

acevia - fromage de tête

présence de listeria monocytogenes

Mar 18, 2026acevia
Food & BeverageFranceRappelConso

acevia - porchetta coussin 1/2

acevia
RappelConsovolontaire (san...

acevia - porchetta coussin 1/2

présence de listeria monocytogenes

Mar 18, 2026acevia
Food & BeverageUSFDA Food

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

CNC Noodle Corporation
FDA FoodClass II

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.

Mar 18, 2026CNC Noodle Corporation
Food & BeverageFranceRappelConso

laleu - magret de canard séché tranché au poivre

laleu
RappelConsovolontaire (san...

laleu - magret de canard séché tranché au poivre

non conformité microbiologique

Mar 18, 2026laleu
Food & BeverageFranceRappelConso

primark - gourde cinnamoroll - 500ml

primark
RappelConsovolontaire (san...

primark - gourde cinnamoroll - 500ml

ce produit ne satisfait pas aux exigences de la norme en 14350

Mar 18, 2026primark
Food & BeverageUSFDA Food

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Palmetto Gourmet Foods Inc.
FDA FoodClass II

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Vegetable oil***" Contains: Wheat, Soy. UPC 8 10037 81061 5 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Product contains undeclared Yellow #5

Mar 18, 2026Palmetto Gourmet Foods Inc.
Food & BeverageUSFDA Food

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.

Willamette Valley Pie Company, LLC
FDA FoodClass II

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.

Mar 18, 2026Willamette Valley Pie Company, LLC
Medical DeviceUSFDA Devices

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

KOB GmbH
FDA DevicesClass II

MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.

Mar 18, 2026KOB GmbH
Medical DeviceUSFDA Devices

Artelon FlexBand Plus Ref: 41054 & 41057

International Life Sciences
FDA DevicesClass II

Artelon FlexBand Plus Ref: 41054 & 41057

Augmentation devices failed bacterial endotoxin testing.

Mar 18, 2026International Life Sciences
Medical DeviceUSFDA Devices

GEM Premier 5000; Part No: 00055415011.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000; Part No: 00055415011.

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

GEM Premier 5000 PAK; Part No. 00055407510.

Instrumentation Laboratory
FDA DevicesClass II

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

Waldemar Link GmbH & Co. KG (Mfg Site)
FDA DevicesClass II

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Mar 18, 2026Waldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceUSFDA Devices

GEM Premier 5000 PAK; Part No. 00055407511.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000 PAK; Part No. 00055407511.

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

GEM Premier 5000 PAK; Part No. 00055360011.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000 PAK; Part No. 00055360011.

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

GEM Premier 5000 PAK; Part No. 00055407508.

Instrumentation Laboratory
FDA DevicesClass II

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

Penner Patient Care, Inc.
FDA DevicesClass III

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

The device does not bear a unique device identifier.

Mar 18, 2026Penner Patient Care, Inc.
Food & BeverageUSFDA Food

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Palm oil***" Contains: Wheat, Soy. UPC 8 10037 81004 2 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Palmetto Gourmet Foods Inc.
FDA FoodClass II

VEGETARIAN CHICKEN FLAVOR RAMEN Express Net wt 3oz (85g) Ingredients: Enriched unbleached flour (wheat flour***) Palm oil***" Contains: Wheat, Soy. UPC 8 10037 81004 2 Produced by PALMETTO GOURMET FOODS, INC SALUDA, SC 29138

Product contains undeclared Yellow #5

Mar 18, 2026Palmetto Gourmet Foods Inc.
Medical DeviceUSFDA Devices

GEM Premier 5000; Part No. 00055445008.

Instrumentation Laboratory
FDA DevicesClass II

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

GEM Premier 5000; Part No. 00055445004.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000; Part No. 00055445004.

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.

Mar 18, 2026Instrumentation Laboratory
Medical DeviceUSFDA Devices

Penner Pacific Bathing Spa, Model Numbers 860010-1L

Penner Patient Care, Inc.
FDA DevicesClass III

Penner Pacific Bathing Spa, Model Numbers 860010-1L

The device does not bear a unique device identifier.

Mar 18, 2026Penner Patient Care, Inc.
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