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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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21 recalls that day

Medline Reprocessed Electrophysiology and Ultrasound Catheters

Reprocessed electrophysiology catheters may contain small particles of residual material, posing a risk of inflammatory response or systemic infection.

High risk, FDA, Foreign object

Bard Access Systems Catheters, Dialysis Catheters, and Biopsy Trays

Bard Access Systems Catheters, Dialysis Catheters, and Biopsy Trays contain lidocaine ampoules that were manufactured under deficient manufacturing practices.

Moderate risk, FDA, Manufacturing problem

BD Medline 111 Gravity Set

The gravity set labeled "Not for Human Use" was shipped to the U.S. market.

Moderate risk, FDA, Unapproved product

Medtronic Harmony Delivery Catheter System

The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.

High risk, FDA, Manufacturing problem

Solar GI System (Water Perfusion)

The Solar GI System can accumulate moisture inside its tubing, affecting airflow or pressure measurement.

Moderate risk, FDA, Device defect

Covidien Shiley Disposable Decannulation Plug

The product labeling incorrectly includes a symbol indicating non-DEHP, but the product includes 30 to 35% DEHP.

Moderate risk, FDA, Labeling error

Masimo Radius VSM ECG Sets and NIBP Cuffs

Radius VSM ECG pre-connected Set and Radius VSM Disposable NIBP Cuff may have issues that could delay treatment or cause skin irritation.

Moderate risk, FDA, Device defect

The Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet specifications.

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

LifeSouth Community Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99158

LifeSouth Community Blood Centers Platelets, Pathogen Reduced

Platelets, Pathogen Reduced did not meet specifications.

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

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99156

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

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

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99150

16 recalls that day

Eunha Fisheries Sliced Korean Halibut and Flounder Sashimi

Sliced Korean Halibut and Flounder Sashimi contain undeclared allergens wheat, soy, and sesame, which can cause serious allergic reactions.

Moderate risk, FDA, Undeclared wheat

Lupin Pharmaceuticals Glucagon Emergency Kit for Low Blood Sugar

The kit has a CGMP deviation: an out-of-specification result in the gliding force functionality test during stability testing.

Moderate risk, FDA, Quality testing problem

Ocular Plus and Vista MAX Dietary Supplements

Ocular Plus and Vista MAX dietary supplements contain undeclared Yellow#5.

Moderate risk, FDA, Undeclared color or additive

Hikma Gemcitabine Injection

Gemcitabine Injection was stored incorrectly.

Moderate risk, FDA, Processing problem

Zeiss Intrabeam Spherical Applicator 1.5 cm

The spherical applicator, a radiation therapy accessory, failed to meet manufacturing specifications.

Moderate risk, FDA, Quality testing problem

Siemens ARTIS Icono Ceiling

The ARTIS icono ceiling has a potential issue with the suspension that holds the monitor, and screws may loosen over time.

Moderate risk, FDA, Device defect

Aligned Medical Solutions Surgical Convenience Kits

Surgical convenience kits contain alcohol prep pads that may be contaminated.

High risk, FDA, Contamination

RaySearch RayCare Oncology Information Systems

Beam set delivery notes in RayCare have potential data loss when a note is updated during a treatment session.

Moderate risk, FDA, Device defect

Hillrom Volara Circuit Kits

There have been reports of air and medication leakage from the nebulizer cup during therapy.

High risk, FDA, Device defect

Medela ENFit Enteral Extension Sets

ENFit ExSet Strl 60 may contain incorrect connectors and will not attach or misconnect to ENFit connections.

Moderate risk, FDA, Device defect

Siemens ARTIS Icono Biplane, Ceiling and Floor

The product may have potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

Moderate risk, FDA, Device defect

Accuray CyberKnife Treatment Delivery System and Linear Accelerator

A collimator may not fully dock, triggering an interlock and preventing motion from the console.

Moderate risk, FDA, Device defect

Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators

CRE Pro Wireguided and CRE Wireguided devices may have a sterile breach of their pouches.

Moderate risk, FDA, Sterility problem

Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller

The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.

Moderate risk, FDA, Device defect

Pilling Wecksorb Neurosponges and Neurosponge Strips

The product has out-of-specification levels of endotoxins.

Moderate risk, FDA, Quality testing problem

Baxter Adapter for Head Positioning

The Adapter for Head Positioning may become loose during patient positioning and move.

Moderate risk, FDA, Device defect

9 recalls that day

Synjardy XR Tablets (Empagliflozin and Metformin Hydrochloride Extended-Release Tablets)

An incorrect detergent was used and required swab sampling was not performed on a production hopper.

Moderate risk, FDA, Manufacturing problem

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Lupin Prednisolone Acetate Ophthalmic Suspension

The ophthalmic suspension contains a foreign substance.

Moderate risk, FDA, Foreign object

Remel GC Agar Base

GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.

Moderate risk, FDA, Device defect

Hamilton Medical Coaxial Breathing Circuit Sets

The coaxial breathing circuit may have expiratory valve membranes sticking, causing an exhalation obstructed alarm and inadequate ventilation.

High risk, FDA, Device defect

The Blood Connection Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were not tested to verify white blood cell count.

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

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99149

Vitalant Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were collected with a potential for air contamination.

Moderate risk, FDA, Ended, Hospital use, Contamination

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

Apheresis Platelets, Leukocytes Reduced, Irradiated had a platelet count higher than acceptable.

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

11 recalls that day

Bosco's Blend Chicken Doggone Raw

Bosco's Blend Chicken Doggone Raw may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

CareFusion 213 BD ChloraPrep and PurPrep Applicators

CareFusion 213 BD ChloraPrep and PurPrep Applicators may lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Accord BioPharma Imuldosa Injection

Imuldosa injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Le Chef Bakery Mini Tiramisu and Italian Pastry Assortment

Le Chef Bakery branded Mini Italian Pastry Assortment and Mini Tiramisu contain undeclared colors.

Moderate risk, FDA, Ended, Undeclared color or additive

Oribe Serene Scalp Densifying Shampoo

Oribe Serene Scalp Densifying Shampoo may be contaminated with bacteria that can infect people with weakened immune systems.

Moderate risk, FDA, Contamination

Medline Convenience Kits

The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM).

Moderate risk, FDA, Device defect

Depuy Synthes Attune Revision Hinge Knee Components

The external sterile packaging was found adhered to the internal sterile packaging.

Moderate risk, FDA, Sterility problem

Medacta Short Monobloc Stem Broaches

Short Monobloc Stem Broaches may increase the risk of fracture in the medial region of the proximal humerus.

Moderate risk, FDA, Device defect

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were not tested for hemoglobin and residual white blood cell count.

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

OneBlood Apheresis Red Blood Cells

Apheresis Red Blood Cells, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.

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

West TN Regional Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced were distributed without pH testing.

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