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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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13 recalls that day

Immunotech Estrone RIA

Estrone RIA may rarely give falsely high patient results, which might cause temporary injury.

Moderate risk, FDA, Device defect

Bard Peripheral Vascular Broviac Single-Lumen CV Catheter Cutdown Tray

The Broviac catheter tray has a damaged outer tray that can compromise the sterile barrier.

Moderate risk, FDA, Sterility problem

Medline IV Administration and Extension Sets

IV administration and extension sets may leak, crack, or break during use, causing treatment delays, blood loss, infection, air embolism, or underdosage.

Moderate risk, FDA, Device defect

Medica Capillary Tubes and EasyBloodGas/EasyStat Capillary Tube Kit

Medica Capillary Tubes can falsely elevate potassium results in patient samples.

Moderate risk, FDA, Device defect

New York Blood Center Apheresis Platelets, Leukocytes Reduced

The platelets were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Community Blood Center of Greater Kansas City Apheresis Red Blood Cells

Leukoreduced Apheresis Red Blood Cells products, collected from a donor whose health history screening was not adequately performed, were distributed.

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

7 recalls that day

Garcia Nevett Crunchy Caramel Dark Chocolate

Crunchy Caramel artisan dark chocolate contains undeclared milk.

Moderate risk, FDA, Ended, Undeclared milk

Aonic Complete Hers and His

Aonic Complete liquid dietary supplement drink shots may be contaminated with coliforms, E.coli, and/or Pseudomonas aeruginosa.

Moderate risk, FDA, E. coli

Fresenius Kabi Compounding Acyclovir, Ketamine, Thiamine and Vancomycin Injections

Acyclovir sodium, ketamine HCl, thiamine HCl, and vancomycin HCl injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Ventura Foods Creamy Peanut Butter and Peanut Butter with Jelly Packs

Creamy peanut butter contains pieces of blue plastic found during production.

Moderate risk, FDA, Ended, Foreign object

Intuitive Surgical da Vinci 5 Surgeon Console Viewer Display

The da Vinci 5 Surgeon Console Viewer Display has outdated firmware that may cause loss of 3D or complete visualization, potentially leading to injury.

Moderate risk, FDA, Software defect

Steris Barco MNA with HexaVue IP Integration System

The Barco MNA with the HexaVue IP Integration System was made with an incorrect configuration file.

Moderate risk, FDA, Device defect

Surepulse VS Newborn Heart Rate Monitor Caps

Surepulse VS Cap has labeling with an incorrect sizing guide.

Low risk, FDA, Labeling error

13 recalls that day

Junebar Chocolate Cherry and Peanut Chocolate Chip All Natural Snack Bar

Junebar snack bars contain undeclared milk and soy, which can cause serious or life-threatening allergic reactions.

High risk, FDA, Ended, Undeclared milk

Wellsley Farms Farm-Raised Atlantic Salmon

Wellsley Farms Farm-Raised Atlantic Salmon may be contaminated with Listeria.

Moderate risk, FDA, Listeria

MG Foods Spicy Breakfast Burritos

The Spicy Breakfast Burrito contains small hard plastic fragments.

Moderate risk, FDA, Ended, Foreign object

Island Crab Smoked Grouper Dip

Smoked Grouper Dip contains undeclared milk, eggs, and sodium metabisulfite.

Moderate risk, FDA, Ended, Undeclared milk

Red Button Movie House Popcorn

Red Button Movie House Popcorn may contain foreign material.

Moderate risk, FDA, Ended, Foreign object

Sodexo Stars Saccharin (Pink) Packets, Sugar Substitute

Sodexo Stars Saccharin packets contain undeclared aspartame.

Low risk, FDA, Ended, Undeclared color or additive

Asteria Health Estradiol and Testosterone Sterile Pellets

Estradiol and Testosterone sterile pellets may contain metal particulate matter.

Moderate risk, FDA, Foreign object

Unichem Doxazosin Tablets

Doxazosin Tablets are imprinted with the wrong ID.

Low risk, FDA, Labeling error

Meitheal Pharmaceuticals Cetrorelix Acetate for Injection (Kit)

Cetrorelix Acetate for Injection kits may have missing or duplicated needles.

Moderate risk, FDA, Device defect

Philips Azurion Systems

Azurion systems may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

Moderate risk, FDA, Device defect

Laerdal Compact Suction Unit 4 RTCA Version

The Laerdal Compact Suction Unit 4 Rtca version may emit electromagnetic noise beyond acceptable limits.

Moderate risk, FDA, Device defect

ATEC Lateral Navigation Disc Prep Instruments

ATEC Lateral Navigation Disc Prep Instruments have a design issue with incorrect navigated array connection geometry.

Moderate risk, FDA, Device defect

American Red Cross Norfolk Main Site Apheresis Platelets and Red Blood Cells

American Red Cross Norfolk Main Site cells, for which Babesia testing was not performed, were distributed.

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

5 recalls that day

McCain Ore-Ida Tater Tots and Sonic Tots

Ore-Ida Tater Tots shaped potatoes and Sonic Tots contain foreign material (small hard plastic fragments).

Moderate risk, FDA, Ended, Foreign object

Accord BioPharma Udenyca Prefilled Syringe

Udenyca injection was stored at room temperature instead of refrigerated.

High risk, FDA, Processing problem

American Health Packaging Oxycodone Hydrochloride Tablets

Oxycodone Hydrochloride Tablets have defective card seals, causing tablets to fall out.

Moderate risk, FDA, Packaging defect

Elekta Leksell GammaPlan Radionuclide RT Treatment Planning System

Leksell GammaPlan treatment planning software has an error that may irradiate the incorrect patient location.

Moderate risk, FDA, Device defect

American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated

American National Red Cross - Johnstown, PA products, for which Babesia testing was not performed, were distributed.

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

4 recalls that day

Pro Numb Tattoo Numbing Spray

Pro Numb Tattoo Numbing Spray has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Halyard Transport Bag Kit

The Halyard Transport Bag Kit has a Tyvek bag seal issue that may compromise sterility.

Moderate risk, FDA, Sterility problem

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