Skip to main content

FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,974 recalls Dates are when each recall was announced (how we date recalls).
Filters · 1Sort Newest
Agency
Risk level
Status
Date
Sold in

4 recalls that day

Straumann WB Impression Post Closed Tray

The impression post closed tray contains magenta caps instead of brown caps.

Low risk, FDA, Device defect

Medline Medical Convenience Kits

Medline medical convenience kits may have an open seal on the packaging of the applicators.

Moderate risk, FDA, Device defect

8 recalls that day

Trividia Health TRUE METRIX Blood Glucose Meter Owner's Booklets and Instructions

The labeling for True Metrix blood glucose meters does not adequately explain the E-5 error code, which could delay treatment.

High risk, FDA, Labeling error

Preema Brand Bright Red Food Colour Powder

Preema brand Bright Red Food Colour Powder contains banned color and undeclared dyes that may affect children's activity and attention.

Moderate risk, FDA, Undeclared color or additive

Kirkland Signature Costco Mini Beignets Filled with Caramel

Kirkland Signature Mini Beignets filled with Caramel have undeclared hazelnut.

High risk, FDA, Ended, Undeclared tree nut

Philips Brilliance iCT and Spectral CT Scanners

Some fasteners in the CT system may not be torqued to specification.

Moderate risk, FDA, Device defect

Hologic Brevera Breast Biopsy System Disposable Needle

The Brevera Breast Biopsy System Disposable 9 Gauge Needle contains particulates that can be deposited into breast tissue during use.

Moderate risk, FDA, Foreign object

Medline ReNewal Reprocessed Diagnostic Catheters

Reprocessed catheters may contain small particles of residual material, posing risks of embolism or thrombosis.

High risk, FDA, Foreign object

Medline Suction Catheter Kits and Intubation Tray

Medline Suction Catheter Kits and Intubation Tray may contain a smaller 8 Fr catheter, which can cause airway obstruction.

Moderate risk, FDA, Device defect

American National Red Cross Red Blood Cells

American National Red Cross Red Blood Cells, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

14 recalls that day

Khee Trading Frozen Half Shell Oysters

Frozen Half Shell Oysters may be contaminated with Norovirus.

Moderate risk, FDA, Ended, Contamination

Taro Diclofenac Sodium Topical Gel 3%

The gel's viscosity is out of specification.

Moderate risk, FDA, Quality testing problem

Granules Trazodone Hydrochloride Tablets

Trazodone Hydrochloride tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Olympus Sphincterotomes

Single Use 3-Lumen Sphincterotome V devices that did not undergo thermoforming could deform and lose performance.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Bubble Sensor

The Bubble Sensor for 3/8" x 3/32" tubing has a durability issue with its connecting cable that can cause sensor damage or loose contact.

Moderate risk, FDA, Device defect

FUJIFILM FDR Visionary Suite

The FDR Visionary Suite X-ray high-voltage generator can overheat and damage parts, possibly causing smoke.

Moderate risk, FDA, Device defect

Stratford Keto-C and Chlorhexidine Ketoconazole Antiseptic Wipes

The product labeled as medicated wipes was found to contain a non-medicated otic flush due to a product mix-up that occurred at the manufacturing level.

Moderate risk, FDA, Labeling error

Green Lumber Natural Fuel For Men Capsules

Green Lumber Natural Fuel For Men capsule contains undeclared tadalafil, a prescription drug, and may cause life-threatening side effects.

High risk, FDA, Hidden drug ingredient

Imu-Tek Immuno-5 Colostrum Powder

Imu-Tek Immuno-5 Colostrum Powder contains an undeclared milk allergen.

Moderate risk, FDA, Ended, Undeclared milk

Molift Mover 205, Mover 300 and Sling Bars

The Molift Mover 205, Mover 300, and sling bars can have a broken bolt that limits joint mobility, preventing proper functionality.

Moderate risk, FDA, Device defect

Handelnine Global Rheumacare Capsules

Rheumacare capsules contain lead.

High risk, FDA, Manufacturing problem

Fujirebio Lumipulse G Plasma Assays, Calibrators and Controls

The tests may produce inaccurate results with a higher frequency of classification in the indeterminate and positive zone and/or low specificity.

Moderate risk, FDA, Device defect

Boston Scientific AXIOS and HOT AXIOS Stent and Delivery Systems

The device has increased reports of stent deployment and expansion issues.

High risk, FDA, Device defect

Wilson-Cook Nasal Jejunal Feeding Tube

The nasal jejunal feeding tube is packaged without the nasal transfer tube component.

Moderate risk, FDA, Device defect

6 recalls that day

Repackaged M&Ms Candies

Beacon Promotions is recalling its Repackaged M&Ms candies and Repackaged M&Ms Peanut candies because they contain undeclared (milk, soy, and peanut).

Moderate risk, FDA, Undeclared milk

Spicely Organic Seasonings

Spicely organic celery salt, garlic salt, and sumac contain salt and are mislabeled.

Moderate risk, FDA, Labeling error

Changchun Wancheng Bio-Electron Urine Test Strips and Cassettes

The test strips were distributed before they could be legally marketed.

Moderate risk, FDA, Device defect

Venzu Traders Cinnamon Powder

Cinnamon powder may be contaminated with lead.

Moderate risk, FDA, Chemical contamination

Willy Pete's Chocolates Almond Despair Dark Chocolate

Almond Despair dark chocolate with coconuts, almonds, and Carolina Reapers has almonds not declared in the ingredient statement.

Low risk, FDA, Ended, Undeclared tree nut

Vortex Surgical Ophthalmic Surgical Instruments

Vortex Surgical Ophthalmic Surgical Instruments may have voids in the seal of Tyvek pouches, potentially leading to infection.

Moderate risk, FDA, Sterility problem

7 recalls that day

Prime Food Processing Dried Croaker Fish

Dried Croaker Fish may not be properly eviscerated, posing a potential health risk.

High risk, FDA, Processing problem

Tradin Organics USA Organic Chia Seed Black

Organic Chia Seed Black may be contaminated with Salmonella.

High risk, FDA, Salmonella

Everpress Juice from the Raw Drinks

JUICE from the Raw, Detox Greens may contain pathogenic bacteria that could harm humans.

High risk, FDA, Ended, Contamination

Focalyx Technologies Focalyx Fusion

The software device's accessories may not function properly with Windows 10.

Moderate risk, FDA, Software defect

Tai Phat Wholesalers Sofit Seedless Red Dates

Sofit, Seedless Red Dates contain undeclared sulfites.

High risk, FDA, Undeclared allergen

Siemens SOMATOM X.Ceed and NAEOTOM Alpha Software Applications

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Moderate risk, FDA, Software defect

B.C. Williams Bakery Service Cake Mixes and Bread and Roll Mix

Spice Cake Mix, Bread and Roll Mix, and Swiss Chocolate Cake Mix contain an undeclared milk allergen.

High risk, FDA, Ended, Undeclared milk

12 recalls that day

Rich Products Gluten Free Vegan Pizza Crust

The gluten free seasoned vegan pizza crust contains undeclared milk and egg.

Moderate risk, FDA, Ended, Undeclared milk

WinCo Foods Deli Margherita Pizza Thin Crust

WinCo Foods Deli Margherita Pizza Thin Crust may contain foreign material (metal fragments).

Moderate risk, FDA, Ended, Foreign object

VITEK 2 Gram-negative Susceptibility Cards

Issue may lead to QC failure or false resistant results.

Moderate risk, FDA, Device defect

Vantive Prismaflex and Oxiris Dialyzer Sets

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Moderate risk, FDA, Device defect

Encore Medical EMPOWR Knee and Hip Implants

The Empowr Acetabular System and Empowr 3D Knee Tibial Insert may have a packaging discrepancy that could cause surgical delay or revision surgery.

Moderate risk, FDA, Packaging defect

Medtronic MiniMed 780G Insulin Pump

A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41.

Moderate risk, FDA, Software defect

Da Vinci X, Xi, and 5 Surgical Systems

The da Vinci surgical systems have a software error that let instrument arms fail a diagnostic test and remain in use.

Moderate risk, FDA, Software defect

Fazt & Loud Lost and Found Energy Drinks

Lost and Found Energy, Sour Gummy Bear has a label misprint that incorrectly states the caffeine content.

Low risk, FDA, Ended, Labeling error

Tornier Perform Reversed Perip Screw

The screws are incorrectly labeled as 5.0mmx18mm but are actually 5.00mmx14mm, which may cause a minor delay or increase risk of mechanical failure.

Moderate risk, FDA, Labeling error

BarbaCuban Sauces, Marinade and Ketchup

BarbaCuban Sauces, Marinade and Ketchup contain undeclared Quinine.

Low risk, FDA, Ended, Undeclared color or additive

Beckman Coulter CellMek SPS Sample Preparation System

The CellMek SPS Sample Preparation System has a software error that can cause sample loss and incorrect diagnosis.

Moderate risk, FDA, Software defect

OptiWize Health Collagen Plus

OptiWize Collagen Plus bottles have manganese levels below the labeled quantity.

Low risk, FDA, Ended, Labeling error

4 recalls that day

Unichem Bisoprolol Fumarate and Hydrochlorothiazide Tablets

Bisoprolol Fumarate and Hydrochlorothiazide tablets may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity