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Food & BeverageFranceRappelConso

disney - fleurs de douche simba -gencod 3666085407553 -tous les lots

disney
RappelConsovolontaire (san...

disney - fleurs de douche simba -gencod 3666085407553 -tous les lots

présence de phtalates dans le badge décoratif amovible associé à la fleur de douche - personnage simba. ces composés ont des effets négatifs sur la santé.

Mar 18, 2026disney
Food & BeverageFranceRappelConso

u - lomo espagnol 20 tranches u 100g

u
RappelConsovolontaire (san...

u - lomo espagnol 20 tranches u 100g

non conformite microbiologique

Mar 18, 2026u
Food & BeverageFranceRappelConso

travel folding electeic kettle bouilloire électrique

Unknown Firm
RappelConsoGeneral Alert

travel folding electeic kettle bouilloire électrique

le produit n'a pas une résistance mécanique suffisante et pourrait donc facilement se casser en cas d'impact ou de chute du produit. de plus, les connecteurs des fils alimentant l'interrupteur bimétallique et l'élément chauffant ne sont pas correctement sertis et pourraient se détacher avec le temps. le produit a également des distances de dégagement insuffisantes. tout cela pourrait rendre les pièces sous tension accessibles à l'utilisateur, qui pourrait recevoir un choc électrique. de plus, la prise électrique n'est pas conforme, ce qui pourrait entraîner une connexion lâche et une surchauffe du produit.

Mar 18, 2026
Food & BeverageUSFDA Food

Lowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case

Uncle Ray's LLC
FDA FoodClass II

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.

Mar 18, 2026Uncle Ray's LLC
Food & BeverageFranceRappelConso

sans marque - gorgonzola dop à la cuillère

sans marque
RappelConsovolontaire (san...

sans marque - gorgonzola dop à la cuillère

présence de listeria monocytogenes.

Mar 18, 2026sans marque
Medical DeviceUSFDA Devices

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Exactech, Inc.
FDA DevicesClass II

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05

Impactor handle may be missing cross-pin

Mar 18, 2026Exactech, Inc.
Food & BeverageFranceRappelConso

- - masques de carnaval

-
RappelConsovolontaire (san...

- - masques de carnaval

un contrôle a mis en évidence l’absence de mise en relief de l’allergène lait dans la liste d’ingrédients du produit.

Mar 18, 2026-
Medical DeviceUSFDA Devices

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

Penner Patient Care, Inc.
FDA DevicesClass III

Penner Pacific Bathing Spa, Model Numbers 360020-1EP

The device does not bear a unique device identifier.

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

House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream, 3 GAL tub

House Of Flavors, Inc.
FDA FoodClass I

House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream, 3 GAL tub

Undeclared egg

Mar 18, 2026House Of Flavors, Inc.
Food & BeverageFranceRappelConso

metro chef - bloc serrano 2.2kg env metro chef

metro chef
RappelConsovolontaire (san...

metro chef - bloc serrano 2.2kg env metro chef

présence de listeria monocytogènes

Mar 18, 2026metro chef
Medical DeviceUSFDA Devices

GEM Premier 5000; Model No. 00055430010.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000; Model No. 00055430010.

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
Food & BeverageUSFDA Food

Made Fresh Salads brand Tofu Whipped; 5 lb white plastic tub

Made Fresh Salads Inc
FDA FoodClass I

Made Fresh Salads brand Tofu Whipped; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Mar 18, 2026Made Fresh Salads Inc
Food & BeverageUSFDA Food

C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8

Tipp Distributors, Inc. dba Novamex
FDA FoodClass III

C2O Coconut Water with Pulp (17.5 oz) 15 Pack UPC: 8-50274-00792-8

The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.

Mar 18, 2026Tipp Distributors, Inc. dba Novamex
Medical DeviceUSFDA Devices

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.

Trividia Health, Inc.
FDA DevicesClass I

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12.

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

Mar 18, 2026Trividia Health, Inc.
Food & BeverageUSFDA Food

Made Fresh Salads brand Sundried Tomato Cream Cheese; 5 lb white plastic tub

Made Fresh Salads Inc
FDA FoodClass I

Made Fresh Salads brand Sundried Tomato Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Mar 18, 2026Made Fresh Salads Inc
Biocheese Pty Ltd - BioCheese Cheddar Shred 200g
FSANZ FoodFood Safety

Biocheese Pty Ltd - BioCheese Cheddar Shred 200g

The presence of an undeclared allergen (milk).

Mar 18, 2026Biocheese Pty Ltd
Food & BeverageUSFDA Food

Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716

Cocos Wholesale and Imports, LLC
FDA FoodClass II

Coco's Italian Market Cannoli Making Kit with 6 Cannoli Shells & Cream, Net Wt. 8 oz. (227g), Keep Frozen, packaged in a plastic container, UPC 0680334992716

Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does not declare wheat or milk.

Mar 18, 2026Cocos Wholesale and Imports, LLC
Medical DeviceUSFDA Devices

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK

Trividia Health, Inc.
FDA DevicesClass I

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK

The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

Mar 18, 2026Trividia Health, Inc.
Medical DeviceUSFDA Devices

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

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

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

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 & BeverageUSFDA Food

Made Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub

Made Fresh Salads Inc
FDA FoodClass I

Made Fresh Salads brand Vegetable Cream Cheese; 5 lb white plastic tub

Products may be contaminated with Listeria monocytogenes.

Mar 18, 2026Made Fresh Salads Inc
Fidget Spinner Ballpoint Pen with LED Light
Australia ProductsButton batteries

Fidget Spinner Ballpoint Pen with LED Light

The product doesn’t comply with the mandatory standards for products containing button/coin batteries. The battery isn’t secured, and children could access the button/coin battery. The product is missing warning information about: the dangers of button/coin batteries to children what to do when a person suspects someone has swallowed or placed a button/coin battery inside any part of their body.

Mar 18, 2026
Medical DeviceUSFDA Devices

GEM Premier 5000 PAK; Part No. 00055407504.

Instrumentation Laboratory
FDA DevicesClass II

GEM Premier 5000 PAK; Part No. 00055407504.

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

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Altruan GmbH
FDA DevicesClass II

Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.

Product not cleared by the FDA.

Mar 18, 2026Altruan GmbH
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