Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 11,751–11,800 of 15,364
- Class II
Medical Device Recall · June 3, 2024
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- Unclassified
Vehicle Recall · June 3, 2024
2024 PREVOST H3-45An electrical short circuit increases the risk of a fire. Additionally, a vehicle fire may require an evacuation procedure in an uncontrolled traffic situation, increasing the risk of injury to passengers.
- Class II
Medical Device Recall · June 3, 2024
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- Class II
Medical Device Recall · June 3, 2024
Fresenius Medical Care Holdings, Inc.
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · June 3, 2024
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiaDuring manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
- Class I
Food Recall · June 3, 2024
New Seasons Market Strawberry Rhubarb Bakewell Tart, packaged in a plastic clamshell with scale label. Contains Milk, Wheat, Eggs.Undeclared almond.
- Class II
Medical Device Recall · June 3, 2024
Fresenius Medical Care Holdings, Inc.
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev AAn increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
- Class II
Medical Device Recall · June 3, 2024
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such thatExpired Products distributed to customers
- Class II
Medical Device Recall · June 3, 2024
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
- Class II
Medical Device Recall · June 3, 2024
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
- Class II
Medical Device Recall · June 2, 2024
Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
- Class II
Medical Device Recall · May 31, 2024
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, thaG5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
- Class I
Medical Device Recall · May 31, 2024
Pneupac paraPAC plus 300 ventilator kit, REF P300NXXThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- Class II
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWLDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- Class III
Food Recall · May 31, 2024
NaturesPlus T-MALE Liquid Testosterone Support for Men 8 OZ Berry and 30 OZ BerryProduct is missing the ingredient TongKat Ali and has additional Rhodiola Rosea
- Class I
Medical Device Recall · May 31, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310NSmiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
- Class I
Medical Device Recall · May 31, 2024
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pumpNine (9) Impella CP pumps failed inspection and were inadvertently released.
- Class II
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive Pro SuperPulsed Laser System, Model TFL-SLSDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- Class II
Medical Device Recall · May 31, 2024
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
- Class II
Medical Device Recall · May 31, 2024
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope,There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse events have been reported to date in direct association with this issue.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: MD39543Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 47552Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Drug Recall · May 31, 2024
Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518-0218-00, Source NDC: 75826-0114-10 MFG: Winder Laboratories, LLC, Winder, GAProduct Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395399Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Medical Device Recall · May 31, 2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cIssue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395415Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395381Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as well as for use in outpatient departments. Material Number: 8627718Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class I
Medical Device Recall · May 31, 2024
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXXThere is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- Class III
Drug Recall · May 31, 2024
Washington Homeopathic Products, Inc.
Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
- Class II
Medical Device Recall · May 31, 2024
Stryker Sustainability Solutions
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnlyMislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number:475517Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class III
Food Recall · May 31, 2024
NaturesPlus ULTRA T-MALE Maximum Strength Testosterone Boost for Men 60 Bi-layer TabletsProduct is missing the ingredient TongKat Ali and has additional Rhodiola Rosea
- Class I
Medical Device Recall · May 31, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300NSmiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
- Class II
Medical Device Recall · May 31, 2024
Olympus Corporation of the Americas
Soltive Premium SuperPulsed Laser System, Model TFL-PLSDifficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergency and accident patients as well as for use in outpatient departments MateriShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Class II
Medical Device Recall · May 31, 2024
MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit ConThe IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.
- Class II
Medical Device Recall · May 31, 2024
Siemens Medical Solutions USA, Inc
AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO and TOP Systems radiographic devices Material Number: 8395431Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
- Unclassified
Consumer Product Recall · May 30, 2024
Black & Decker (U.S.) Inc., of Towson, Maryland
CRAFTSMAN® V20 Cordless Tillers/CultivatorsThe assembly instructions can cause consumers to incorrectly attach the bottom portion of the tiller/cultivator upside down, causing the tines to rotate toward the user, posing a laceration hazard.
- Unclassified
Consumer Product Recall · May 30, 2024
Medline Industries LP, of Northfield, Illinois
Medline Bed Assist Bar adult bed railsWhen the recalled bed rails are attached to an adult's bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
- Class I
Drug Recall · May 30, 2024
Glenmark Pharmaceuticals Inc., USA
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-DFailed Dissolution Specifications
- Class II
Medical Device Recall · May 30, 2024
Dental EZ Group Star Dental Division
Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling andTip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
- Class II
Food Recall · May 30, 2024
Tillamook County Creamery Association
Tillamook Colby Jack/Monterey Jack Cheese Slices, item # 651195, net wt. 32oz, total 42 slices per package, refrigerated, packaged in flexible plastic film, retail package UPC 0 72830 00721 4. Case IPlastic material. The piece of plastic material was detected in a 40lb. cheese block and smaller fragments of the plastic material may be found in the cheese slices.
- Class I
Medical Device Recall · May 30, 2024
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- Class II
Drug Recall · May 30, 2024
Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited,Failed Content Uniformity Specifications
- Class I
Drug Recall · May 30, 2024
Glenmark Pharmaceuticals Inc., USA
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-DFailed Dissolution Specifications
- Class I
Medical Device Recall · May 30, 2024
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
- Class II
Food Recall · May 30, 2024
Heinen's Tuscan Salad Bowl Ingredients: Garbanzo Beans***Disodium EDTA***Arugula, Roasted Corn***Red Bell Pepper, Dried Cranberries***Walnuts***Parmesan Cheese*** Contains: WALNUT, MILKProduct contains undeclared pecans, a known allergen.