Archive
524 recalls were announced in January 2024.
Of the 524 recalls this month scored against our rubric, 2% are Critical, 24% are Severe.
Which agencies issued them
Pierce is recalling 248 Freightliner and International chassis vehicles from 2020-2023 due to a firmware defect that can cause electrical fires.
Busse Hospital Disposables recalls sterile dressing change trays due to inability to guarantee required sterility assurance level. The defect could lead to serious infections including blood stream, urinary tract, or respiratory infections.
Samsung Bean Sprout is recalling Sung Soy Bean Sprouts (1lb packages) distributed to Virginia due to Listeria monocytogenes contamination. Products have a sell-by date of 12/14/23.
Merit Medical Systems is recalling specific lots of microcatheter and infusion system devices because their sterility cannot be guaranteed. The devices were distributed worldwide including multiple US states and international locations.
Philips recalled Trilogy Evo respiratory devices for missing contraindications in labeling. Devices lack warnings against use in pediatric patients under 10 kg and certain therapy modes, risking barotrauma and respiratory complications.
Lucid is recalling 2022-2023 Air vehicles whose high voltage coolant heater may fail to defrost the windshield, reducing visibility and increasing crash risk. Lucid will provide a software update and replace failed heaters at no cost.
Certain 2024 Volvo XC40 vehicles may have a software error in the Central Electronic Module that disables the left rear turn signal indicator, increasing the risk of a crash if other drivers are not notified of turning.
Wegmans Seafood Medley (1 lb packages, Lot 47117) is being recalled because it may contain plastic foreign objects. The recall affects products distributed in Massachusetts, Pennsylvania, and New York.
Foremost Foods International is recalling Pamana Premium Bangus Belly frozen milkfish because the reduced-oxygen packaging lacks instructions to keep the product frozen and to thaw it properly, risking Clostridium botulinum toxin formation.
Foremost Foods International is recalling Pamana Premium Marinated Bangus due to potential botulism risk. The frozen product in reduced oxygen packaging lacks required freezing and thawing instructions.
Natus Medical Incorporated is recalling 2,686 units of External Drainage System Collection Bags due to incomplete bioburden testing that prevents sterility assurance. Healthcare facilities and patients should contact the manufacturer or their healthcare provider for guidance.
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
Spring Valley Biotin & Collagen Liquid is being recalled due to potential mold contamination. Approximately 24,324 units were distributed nationwide; consumers should stop using affected products.
Beaver Visitec International is recalling one lot of surgical knives where the blade is oriented incorrectly—bevel down instead of the required 55-degree bevel up. This defect could compromise surgical precision during use.
Natus Medical is recalling 3,336 units of the EDS 3 CSF External Drainage System nationwide because incomplete bioburden testing cannot guarantee sterility. No illnesses have been reported, but non-sterile devices pose infection risk.
One lot of Xstar Kojo Safety Slit Knife contains inverted blades (bevel down instead of bevel up). The 2160 affected units from lot 6049877 were distributed internationally, including to Japan.
Medtronic is recalling Protege GPS Self-Expanding Peripheral Stent Systems due to seal defects in product packaging that could compromise sterility. Affected lot B644679 had national distribution.
Racine Danish Kringles Raspberry Kringle (14 oz., lot 23299) is being recalled due to undeclared tree nuts (pecans). Consumers with nut allergies should not consume this product.
Scratch PASTA Co Marinara Sauce is recalled because the label does not list milk as a common allergen, despite the product containing milk in its butter ingredient.
Bobo's Oat Bars - Peach are recalled due to undeclared coconut. The recall affects approximately 10,800 units sold under Lot Code 3J27111.
Foremost Foods is recalling Pamana Premium Marinated Baby Bangus due to potential botulism risk. The frozen product in reduced-oxygen packaging lacks required freezing and thawing instructions.
Fresenius Medical Care is recalling 69,590 bags of DELFLEX Peritoneal Dialysis Solution due to lack of sterility assurance. The affected lot was distributed nationwide.
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
Covidien is recalling Valleylab FT10 FT Series Energy Platform devices due to a software issue that may render new systems inoperable. The recall affects 47,901 units distributed worldwide.
Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.
Randox Laboratories recalls SEROLOGY ToRCH lgM 2022 POSITIVE CONTROL (Lot 157SR) due to decreased HSV Type 1/2 reactivity when tested on the DiaSorin Liaison XL analyzer. The product was distributed in New York and West Virginia.
Encore Medical is recalling 17 Reverse Shoulder System e+ surgical implants (Lot 381P1167) due to mislabeling. Affected units were distributed nationwide to multiple states.
Azurity Pharmaceuticals recalls Eprontia (topiramate) oral solution nationwide because routine stability testing found an out-of-specification impurity. The chemical defect raised concerns about the drug's purity and patient safety.
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.
Abiomed has disabled four features in the Impella Connect software portal because the FDA has not evaluated them for safety and effectiveness.
Seaway Pharma is recalling oxymetazoline nasal spray due to manufacturing process deviations. No contamination was found in the final products.
Quality Choice No Drip nasal decongestant is being recalled due to a manufacturing deviation in water purification. No contamination was detected in the finished products.
Quality Choice No Drip Nasal Decongestant is being recalled because purified water used in manufacturing may have contained microbial contamination. No contamination was detected in the final products.
Seaway Pharma Inc. recalled Premier Value Tussin Cough DM due to possible microbial contamination in manufacturing water. No contamination was found in finished products and no illnesses have been reported.
PL Custom is recalling 2020-2024 Type 1 and Type 3 ambulances because a firmware defect may cause electrical circuits to overheat and catch fire.
Alexis Fire Equipment is recalling 56 fire trucks from 2022-2023 because a firmware defect may prevent electrical circuits from shutting off, increasing fire risk.
E-One is recalling 408 fire trucks because a wiring defect may cause electrical circuits to overheat and start a fire.
Marion Body Works is recalling 2024 Spartan Fire MetroStar vehicles because a defective inversion valve may delay parking brake engagement, increasing the risk of unintentional vehicle movement.
Forest River is recalling Coachmen Galleria motorhomes (2020–2024) because battery boost wiring may become damaged, causing an electrical short circuit that results in loss of power steering, increasing crash risk.
Salm Partners, LLC is recalling ready-to-eat turkey kielbasa products due to possible contamination with bone fragments.
Forest River is recalling 2020 Cherokee travel trailers because the draw bar locking mechanism may break, causing the trailer front to contact the road and increasing crash risk.
USDA FSIS issued a public health alert for Wild Fork Porcini Mushroom Risotto Bites that may contain undeclared sesame. Consumers with sesame allergies should not consume these products.
Mickey Truck Bodies is recalling 37 commercial trucks from 2020-2023 because exposed wiring on the refrigeration unit may cause electrical arcing and increase fire risk.
Braun Northwest is recalling 2020-2021 Northstar ambulances because a firmware defect may cause electrical circuits to overheat and increase the risk of fire.
Terex Advance is recalling 2023-2024 concrete mixer trucks because bolts may loosen, causing the drum to separate from the vehicle.
Ride Aventon is recalling about 2,300 Class 2 Sinch.2 folding e-bicycles because they can accelerate unexpectedly, causing loss of control and crash hazards. The firm has received six reports of unexpected acceleration but no injuries.
Bell Sports is recalling about 2,360 Bell Slope Adult Helmets because the strap anchor can dislodge during impact, violating safety standards and risking head injury in a crash.
Homedics is recalling about 46,000 Therapist Select Percussion Personal Massagers (model HHP-715) because they can overheat while charging, creating fire and burn risks. The company has received 17 overheating reports, including one burn injury.
UBBCARE play yard mattresses violate federal safety standards for crib mattresses and pose a suffocation hazard to infants. The mattresses are missing required warnings and labels and fail thickness tests. No injuries have been reported.
H.H. Brown Shoe Company is recalling about 2,360 Redeemer DH 5379 work boots sold from February 2023 through October 2023 because the sole is not puncture-resistant, posing an injury hazard. No injuries have been reported.
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product is now restricted to patients age 12 and older.
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
Fratelli Beretta USA is recalling Busseto Foods charcuterie samplers due to possible Salmonella contamination linked to a multistate outbreak investigation.
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in patients age 12 and older.
Brut Classic Antiperspirant & Deodorant in 4 oz and 6 oz aerosol cans is being recalled due to benzene contamination. The recall affects all lots distributed in the United States and Canada.
Spektrum Brakes is recalling Dynamic Friction R1 brake rotors because the hub can fracture, causing a loss of braking ability and increasing crash risk.
Sure Regular Antiperspirant Deodorant Aerosol (6 oz cans) sold nationwide in the US and Canada is being recalled due to benzene contamination. All lots expiring on or before August 2023 are affected.
Sure Unscented Deodorant Aerosol is being recalled nationwide due to benzene contamination. Consumers should stop using affected cans and contact the manufacturer.
Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.
Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.
Magnum XXL 9800 capsules contain undeclared sildenafil and were marketed without FDA approval. The product was distributed nationwide via Amazon.
Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before use.
Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.
Cardinal Healthcare recalls Warfarin Sodium tablets distributed nationwide due to products being exposed to improper storage temperatures.
The Medtronic SynchroMed II pump may fail to resume drug delivery after MRI if electromagnetic interference triggers telemetry mode while the pump is alarming. This could interrupt essential medication delivery in patients.
Cardinal Healthcare recalls batch 62002532 of Wixela Inhub inhalation powder nationwide due to CGMP deviations. Products were exposed to temperatures outside labeled storage conditions, potentially affecting product stability.
Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.
Atrium Oasis surgical drain recalled due to sterilization nonconformance that shortened the product's shelf life. Affected units were distributed nationwide and may not maintain sterility if used after November 17, 2025.
Landauer microSTARii readers may provide inaccurate dosimetry measurements due to LED beam profile issues and debris formation. Inaccuracy may not be detected without regular quality control testing. 584 units affected worldwide.
Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.
Legacy Pharmaceutical Packaging LLC is recalling 161,664 bottles of Sertraline Hydrochloride 100 mg tablets distributed in California and Arkansas due to inadequate line clearance during manufacturing that may result in product comingling.
Cardinal Healthcare is recalling low-dose aspirin tablets nationwide due to a CGMP deviation involving improper storage temperatures. Products may have been exposed to conditions outside the manufacturer's labeled storage requirements, potentially affecting product stability.
Bumetanide tablets manufactured by Amneal Pharmaceuticals are being recalled because they were exposed to temperatures outside their labeled storage conditions. The recall affects batch AM211171 distributed nationwide.
Cardinal Healthcare recalled Lithium Carbonate Extended-Release Tablets (300 mg, Batch 3138326) distributed nationwide because the products were exposed to temperatures outside their labeled storage conditions during manufacturing.
Cardinal Healthcare is recalling Nyamyc topical antifungal medication (Batch 400454) nationwide due to exposure to temperatures outside labeled storage conditions.
Cardinal Healthcare is recalling an ipratropium bromide and albuterol sulfate inhalation solution nationwide after the product was exposed to temperatures outside labeled storage conditions. The deviation may affect drug potency.
Sandoz Inc is recalling Enoxaparin Sodium Injection (batch SAH06821A) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling Donepezil Hydrochloride 5 mg tablets (Batch 17605) distributed nationwide because they were exposed to temperatures outside labeled storage conditions, which could affect drug stability.
Arjo medical beds with IndiGo Drive Assistance modules may experience unintended wheel movement. The recall affects 846 units distributed across seven US states.
Cardinal Healthcare recalls Warfarin Sodium Tablets (5 mg) nationwide due to CGMP deviations: products were exposed to temperatures outside labeled storage conditions, potentially affecting drug stability.
Cardinal Healthcare is recalling Amoxicillin 875mg tablets due to CGMP deviations where products were exposed to temperatures outside their labeled storage conditions, affecting nationwide distribution.
DeRoyal Industries is recalling a cardiac catheterization kit that contains Edwards Life Sciences pressure transducers that were subject to a separate recall by their manufacturer.
Acumed LLC recalls 513 RibLoc U Plus 90 surgical guides due to potential breakage during use. The device is used in orthopedic rib fixation procedures.
Cardinal Healthcare is recalling Rivastigmine Transdermal System patches (4.6 mg/24 hours) distributed nationwide because they were exposed to temperatures outside labeled storage conditions during manufacturing.
A prescription lansoprazole suspension has been recalled because batches were exposed to temperatures outside the manufacturer's labeled storage range. This manufacturing quality issue affects Batch 21025A nationwide.
Publix Super Markets is recalling Egg Custard Pie due to undeclared coconut, a tree nut allergen. Consumers with coconut allergies should not consume the product.
Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) are being recalled nationwide due to temperature exposure during manufacturing that fell outside labeled storage conditions. Affected batches are 21000279A and 21000280A.
AnazaoHealth Corporation is recalling 3,363 vials of Thiamine HCl/Pyridoxine HCl injection solution nationwide due to the presence of particulate matter. Affected lots are identified by lot numbers and expiration dates listed by the FDA.
Cardinal Healthcare is recalling Estradiol 0.5mg tablets (Batch 100023687) nationwide due to exposure to temperatures outside labeled storage specifications. Temperature exposure may affect medication stability.
Abbott Laboratories is recalling 8,424 Alinity ci-series System Control Module units due to software performance issues that could produce erroneous test results. Affected systems are used in clinical laboratories throughout the United States and 90+ countries.
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.
Cardinal Healthcare is recalling Hydralazine Hydrochloride tablets nationwide because products were exposed to temperatures outside labeled storage conditions due to manufacturing practice deviations.
The Medtronic SynchroMed II pump may fail to resume medication delivery after an MRI scan if the device switches to telemetry mode due to electromagnetic interference while alarming. The pump will not resume normal operation after leaving the MRI magnetic field.
Cardinal Healthcare is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide. Batch 2447J211 was exposed to temperatures outside labeled storage conditions, which could compromise medication effectiveness.
AnazaoHealth is recalling B-Complex injection vials due to particulate matter contamination. Affected patients should discontinue use and consult their healthcare provider.
Donepezil Hydrochloride 10mg tablets are recalled due to exposure to temperatures outside labeled storage conditions. The FDA classified this Class II recall due to potential effects on drug stability.
Cardinal Healthcare is recalling Albuterol Sulfate inhalers (Batch K100715) due to CGMP deviations where products were exposed to temperatures outside labeled storage conditions. Approximately 11 cartons were distributed nationwide. Contact your pharmacist or doctor for a replacement.
Cardinal Healthcare is recalling Meloxicam 15 mg tablets nationwide due to exposure to temperatures outside labeled storage conditions. No adverse events have been reported.
Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.
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