Safety Recalls

15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 12,051–12,100 of 15,364

• Consumer Product Recall · May 9, 2024

  Trademango Solutions Inc., dba Article, of Canada

  Spin Swivel Chairs

  The swivel chair's base can break, posing a fall hazard.

  Unclassified

• Medical Device Recall · May 9, 2024

  C.R. Bard Inc

  Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Gua

  Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

  Class II

• Consumer Product Recall · May 9, 2024

  Textron Specialized Vehicles, of Augusta, Georgia

  Arctic Cat Model Year 2024 Catalyst 600 snowmobiles

  The steering caps, which are used to hold the handlebar in place, can crack and cause the handlebars to become unstable, posing a crash hazard.

  Unclassified

• Consumer Product Recall · May 9, 2024

  ZLINE Kitchen and Bath, of Reno, Nev.

  ZLINE Wall Ovens

  The oven door hinge can dislodge, releasing the spring, which can damage or break through the door trim, posing an impact injury hazard to consumers.

  Unclassified

• Medical Device Recall · May 9, 2024

  Echonous Inc

  Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

  Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

  Class II

• Medical Device Recall · May 9, 2024

  Sol-Millennium Medical Inc.

  Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1

  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  Class II

• Medical Device Recall · May 9, 2024

  Sol-Millennium Medical Inc.

  Syringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899; b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space

  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  Class II

• Medical Device Recall · May 9, 2024

  Stryker GmbH

  Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

  The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

  Class II

• Vehicle Recall · May 9, 2024

  Chrysler (FCA US, LLC)

  2023 JEEP GLADIATOR, 2023 JEEP WRANGLER, 2024 JEEP GLADIATOR

  An instrument panel that fails to display critical safety information, such as the speedometer or warning lights, can increase the risk of a crash.

  Unclassified

• Medical Device Recall · May 9, 2024

  Sol-Millennium Medical Inc.

  Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N

  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  Class II

• Medical Device Recall · May 9, 2024

  First Source Inc

  First Source iQ Flex M. Portable cart and platform that supports an X-ray system and laptop computer.

  Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

  Class II

• Medical Device Recall · May 9, 2024

  Sol-Millennium Medical Inc.

  Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET,

  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  Class II

• Vehicle Recall · May 9, 2024

  Porsche Cars North America, Inc.

  2024 PORSCHE TAYCAN

  Incorrect headlight control module software may cause the parking lights not to operate as intended when the turn signals are activated, which can reduce vehicle visibility and increase the risk of a crash.

  Unclassified

• Food Recall · May 9, 2024

  New Classic Cooking LLC

  Veggies Made Great brand Broccoli Cheddar Breakfast Potato Bakes. Net Wt. 36 OZ (2.25 LB) 1.02 KG. UPC: 70486300103. Frozen product. Individually wrapped in flowrap, 18 bakes per box.

  Possible Listeria monocytogenes contamination

  Class II

• Consumer Product Recall · May 9, 2024

  Shanghai Yangxi Dian Zi Shang Wu You Xian Gong Si, DBA Yangxi, of China

  Korimefa Multi-Purpose Bike Helmets

  The recalled helmets do not comply with the positional stability requirements of the CPSC federal safety standard for bicycle helmets. The helmets can fail to protect in the event of a crash, posing a risk of head injury.

  Unclassified

• Consumer Product Recall · May 9, 2024

  Textron Specialized Vehicles, of Augusta, Georgia

  Prowler Pro and Tracker 800SX Utility Vehicles (UTVs)

  The fuel tank cap does not fit correctly, causing a fuel leak around the filler neck, posing a fire hazard.

  Unclassified

• Medical Device Recall · May 9, 2024

  Sol-Millennium Medical Inc.

  Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 8100180975

  Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  Class II

• Medical Device Recall · May 9, 2024

  First Source Inc

  First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.

  Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient.

  Class II

• Medical Device Recall · May 9, 2024

  Remote Diagnostic Technologies Ltd.

  Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

  Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

  Class II

• Consumer Product Recall · May 9, 2024

  SIORO, of China

  SIORO Children's Robes

  The children's robes violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.

  Unclassified

• Consumer Product Recall · May 9, 2024

  Zegoo Home, of China

  Zegoo Children's Nightgowns

  The children's nightgowns violate the flammability standards for children's sleepwear, posing a risk of burn injuries to children.

  Unclassified

• Consumer Product Recall · May 9, 2024

  Cotton On USA Inc., of La Mirada, California

  Toy Pinwheels

  The pinwheel's fastener cap can come loose and detach, posing a choking hazard to young children.

  Unclassified

• Medical Device Recall · May 8, 2024

  Baxter Healthcare Corporation

  Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.Multiple model numbers of Centrella Max ma

  There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.

  Class II

• Food Recall · May 8, 2024

  BonBon NYC LLC.

  Marabou Sea Salt Chocolate Bar; 185g; yellow plastic packaging and the word 'havvsalt', the Swedish word for "sea salt"; product is a flat chocolate bar

  Product may contain undeclared almonds, wheat, and nuts.

  Class I

• Food Recall · May 8, 2024

  Texas Pecan Co

  1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds

  Potential cross-contamination with tree nuts, peanuts, milk, soy, sesame, & wheat.

  Class II

• Medical Device Recall · May 8, 2024

  Becton, Dickinson and Company, BD Biosciences

  BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit w

  Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

  Class II

• Medical Device Recall · May 8, 2024

  Ortho-Clinical Diagnostics, Inc.

  VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS

  The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot. As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.

  Class III

• Drug Recall · May 8, 2024

  Lupin Pharmaceuticals Inc.

  Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 0

  Defective container: lack of seal integrity.

  Class II

• Medical Device Recall · May 8, 2024

  Megadyne Medical Products, Inc.

  MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.

  Reports of patient burns.

  Class I

• Medical Device Recall · May 8, 2024

  Thoratec Corp.

  Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device

  System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

  Class I

• Food Recall · May 8, 2024

  Della Fattoria, LLC

  Della Fattoria Sicilian Semolina

  Missing the declaration of sesame seeds from the "Contains" statement.

  Class II

• Food Recall · May 8, 2024

  Della Fattoria, LLC

  Della Fattoria Seeded Wheat

  Missing the declaration of sesame seeds from the "Contains" statement.

  Class II

• Food Recall · May 8, 2024

  Texas Pecan Co

  1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds

  Potential cross-contamination with tree nuts, peanuts, milk, soy, sesame, & wheat.

  Class II

• Food Recall · May 8, 2024

  FoodScience, LLC

  Amyloid Complete

  Contains undeclared crustacean shellfish (shrimp & crab)

  Class II

• Medical Device Recall · May 7, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

  Potential for an incomplete seal on the packaging tray.

  Class II

• Medical Device Recall · May 7, 2024

  Blue Belt Technologies, Inc

  CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anat

  CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay

  Class II

• Medical Device Recall · May 7, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated, Compatible w/ FT10 18cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF4418CR.

  Potential for an incomplete seal on the packaging tray.

  Class II

• Medical Device Recall · May 7, 2024

  Integra LifeSciences Corp.

  CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospina

  Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

  Class II

• Medical Device Recall · May 7, 2024

  Integra LifeSciences Corp.

  CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) a

  Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

  Class II

• Drug Recall · May 7, 2024

  MACLEODS PHARMA USA, INC

  Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceut

  Presence of foreign substance: plastic-like substance.

  Class II

• Medical Device Recall · May 7, 2024

  ICU Medical Inc

  Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba

  Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

  Class I

• Medical Device Recall · May 7, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.

  Potential for an incomplete seal on the packaging tray.

  Class II

• Medical Device Recall · May 7, 2024

  Integra LifeSciences Corp.

  CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other

  Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility.

  Class II

• Drug Recall · May 7, 2024

  PACIRA PHARMACEUTICALS INC

  Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-001-

  Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

  Class II

• Medical Device Recall · May 7, 2024

  Becton Dickinson & Co.

  BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.

  Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

  Class II

• Medical Device Recall · May 7, 2024

  MEDLINE INDUSTRIES, LP - Northfield

  Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.

  Potential for an incomplete seal on the packaging tray.

  Class II

• Medical Device Recall · May 7, 2024

  ICU Medical Inc

  Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS

  Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

  Class I

• Medical Device Recall · May 7, 2024

  ICU Medical Inc

  Plum 360/A+ spare batteries. Item Number: SUB0000864.

  Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

  Class I

• Food Recall · May 6, 2024

  GNS Foods, Inc

  Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011

  A recall of lactose or lactose powder from Grande Ingredients in Wisconsin. The ingredient has the potential to be contaminated with Salmonella

  Class II

• Medical Device Recall · May 6, 2024

  American Contract Systems, Inc.

  American Contract Systems Gyn Laparoscopy convenience kit

  Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility

  Class II