Safety Recalls

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15,271 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

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Showing 7,851–7,900 of 15,271

Medical Device Recall · February 18, 2025
GE Medical Systems, LLC
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Class II
Medical Device Recall · February 18, 2025
GE Medical Systems, LLC
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
Product lacks 510(k) clearance.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 6936702
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-IB00180018;
Product lacks 510(k) clearance.
Class II
Food Recall · February 17, 2025
Kenover Marketing Corp.
Glicks Dark Chocolate Conettos, 2.47 oz., Plastic Bag, 24 packages per case
Undeclared Allergen (Milk)
Class I
Medical Device Recall · February 17, 2025
B Braun Medical Inc
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Increased risk for valve housing detachment causing leakage.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
Product lacks 510(k) clearance.
Class II
Drug Recall · February 17, 2025
MEDLINE INDUSTRIES, LP - Northfield
CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA
Subpotent Drug
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filt
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Drug Recall · February 17, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA,
Subpotent Drug
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
9 Coated Regular Tampons and 9 Nude Regular Tampons; Model Number: FG-TMP-RET09000900;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - Microstream Advance Adult-Pediatric Intubated CO
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediat
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 S
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
Product lacks 510(k) clearance.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Lorazepam 0.5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Concentrate, Rx Only, Refrigerate, Mfg by: PAI, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00054353244, b) 00121077001,
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 6961800705
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Drug Recall · February 17, 2025
Safecor Health, LLC
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989;
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
Product lacks 510(k) clearance.
Class II
Medical Device Recall · February 17, 2025
DAYE (ANNE'S DAY LTD)
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
Product lacks 510(k) clearance.
Class II