June 2023 recalls

513 recalls were announced in June 2023.

What the numbers show

Critical: 13
Severe: 177
High: 265
Moderate: 57
Low: 1

Of the 513 recalls this month scored against our rubric, 3% are Critical, 35% are Severe.

Which agencies issued them

101–200 of 513

SevereFDA (Devices)·Z-1752-2023·2023-06-28
Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure
Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.
Product
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1759-2023·2023-06-28
Implantable Cardiac Defibrillators May Fail During High-Voltage Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
Product
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1728-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.
Product
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1765-2023·2023-06-28
Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
Product
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1746-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.
Product
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1821-2023·2023-06-28
Implantable cardiac defibrillators recalled for potential therapy failure risk
Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component.
Product
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1764-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapy in Rare Cases
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may rarely fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough.
Product
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1706-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment
Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.
Product
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0990-2023·2023-06-28
Miyako Select Shredded Crab Meat recalled for undeclared wheat and eggs
Aquamar Inc is recalling Miyako Select shredded crab meat and related crab-flavored seafood products due to undeclared wheat and eggs allergens. The recall affects approximately 31,079 cases distributed across the United States and Canada.
Product
Miyako Select Shredded Crab Meat Keep Refrigerated #1485 Ingredients: Fish Protein (Pollock, Threadfin Bream and/or Flying Fish), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Carrageenan, Natural and Artificial Flavors
Category
Food
Distribution
12 states
SevereFDA (Food)·F-0992-2023·2023-06-28
Kanimi Crab Flavored Seafood recalled for undeclared wheat and eggs
Aquamar Inc is recalling Kanimi Crab Flavored Seafood Fancy Shred due to undeclared wheat and eggs allergens. The product may cause serious health effects in consumers with these allergies.
Product
Kanimi Crab Flavored Seafood Fancy Shred Style 92410 Ingredients: Fish Protein (Pollock, Whiting and or Threadfin Bream), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Natural and Artificial Flavors (Hydrolyzed Soy Prot
Category
Food
Distribution
12 states
SevereFDA (Devices)·Z-1720-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.
Product
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1823-2023·2023-06-28
ICD defibrillators risk reduced or absent therapy output from feedthrough defect
Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and worldwide.
Product
ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1705-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Product
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1715-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
Product
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1713-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.
Product
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1789-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic implantable defibrillators with certain feedthroughs may fail to deliver high-voltage therapy when needed. This rare malfunction could prevent life-saving electrical treatment.
Product
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1739-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Energy Output Failure
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. Affected devices contain a specific glassed feedthrough.
Product
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1801-2023·2023-06-28
Medtronic implantable cardioverter defibrillators recalled for potential reduced-output defect
Medtronic has recalled certain ICD and CRT-D cardiac devices due to a rare risk of reduced or no energy output during high-voltage therapy. The affected models contain a specific glassed feedthrough component.
Product
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1788-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators May Deliver Reduced Energy During High Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high-voltage therapy. Approximately 2,142 affected units have been identified.
Product
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1806-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design defect.
Product
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1793-2023·2023-06-28
Implantable Defibrillators May Produce Reduced or No Energy Output
Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed worldwide.
Product
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1780-2023·2023-06-28
Medtronic ICD COBALT XT implants may deliver reduced or no therapy
Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.
Product
ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1751-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.
Product
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1708-2023·2023-06-28
Implantable Cardioverter Defibrillators with defective feedthrough may fail therapy delivery
Medtronic's EVERA XT implantable cardioverter defibrillators may fail to deliver therapy due to a rare feedthrough defect affecting 727 units worldwide.
Product
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1822-2023·2023-06-28
Implantable Heart Defibrillators May Fail to Deliver Therapy
Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.
Product
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1729-2023·2023-06-28
Medtronic CRT-D Implants Recalled for Rare Energy Output Failure Risk
Medtronic is recalling certain CRT-D (cardiac resynchronization therapy defibrillator) models due to a rare risk of reduced or no energy output during high-voltage therapy. The FDA has classified this as a Class I recall affecting 1,473 units.
Product
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1800-2023·2023-06-28
Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
Product
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1707-2023·2023-06-28
Implantable Defibrillators Risk Reduced or No Energy Output During Therapy
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.
Product
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1744-2023·2023-06-28
Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure
Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.
Product
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1813-2023·2023-06-28
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected nationwide and worldwide.
Product
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1820-2023·2023-06-28
ICD Cobalt VR MRI Implantable Defibrillators Recall Due to Potential Therapy Failure
Medtronic is recalling 1,930 ICD Cobalt VR MRI implantable defibrillators due to a rare risk of reduced or no-energy output during high voltage therapy. The defect affects units with a specific glassed feedthrough component.
Product
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1811-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Therapy Due to Feedthrough Defect
Medtronic's ICD-VR DVMB2D4 implantable defibrillators may fail to deliver electrical therapy due to a defect in the feedthrough component. The recall affects 6,477 units distributed worldwide.
Product
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1711-2023·2023-06-28
Medtronic Cardiac Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.
Product
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1798-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail To Deliver Therapy; Class I Recall
Medtronic implantable cardioverter defibrillators (ICDs) may fail to deliver high-voltage therapy due to a manufacturing defect in a specific feedthrough component. 447 units are affected worldwide.
Product
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1724-2023·2023-06-28
Medtronic ICD Devices Potential Energy Output Failure During Therapy
Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.
Product
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1802-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.
Product
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1781-2023·2023-06-28
Implantable Cardiac Devices Risk Therapy Failure From Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.
Product
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1731-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.
Product
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1772-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough design issue. This could prevent life-saving electrical therapy from being delivered.
Product
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1745-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic's implantable cardioverter defibrillators may produce reduced or no energy during high voltage therapy due to a feedthrough defect. A total of 1,076 units are affected worldwide.
Product
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2023·2023-06-28
Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.
Product
Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2023·2023-06-28
Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications
Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.
Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1976-2023·2023-06-28
NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability
Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.
Product
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2023·2023-06-28
Single use hemostatic clips recalled for clip deployment and mechanical failures
Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.
Product
Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V452000·2023-06-28
Certain 2021–2025 Lion LionC School Buses Electrical Hardware Recall
Lion Electric is recalling 2021–2025 LionC school buses due to loose electrical hardware that could cause short circuits and loss of steering or braking power. Contact Lion customer service at 1-855-546-6706 for free replacement.
Product
LION — LION LIONC
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2023·2023-06-28
Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.
Product
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0998-2023·2023-06-28
Wegmans Penne Rigate Mozzarella Salad recalled for undeclared milk allergen
Wegmans Penne Rigate Mozzarella Salad is being recalled due to undeclared milk allergen. Affected products were distributed to stores in New York, Pennsylvania, and Massachusetts.
Product
Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ (1 LB 14 OZ) 850 g. Packaged in a plastic container.
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1984-2023·2023-06-28
Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings
Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.
Product
Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1981-2023·2023-06-28
KARL STORZ sterilization trays recalled for inadequate model-specific instructions
FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.
Product
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1712-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure
Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.
Product
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1002-2023·2023-06-28
Julian's Recipe Cauli-Wafels recalled for undeclared soy allergen
Julian's Recipe Original Cauli-Wafels are recalled due to undeclared soy lecithin. Consumers with soy allergies face risk of allergic reaction.
Product
Julian's Recipe Original Cauli-Wafels, 7.41 oz.
Category
Food
Distribution
4 states
HighFDA (Food)·F-0989-2023·2023-06-28
TYR Anamix Early Years infant formula recalled for undeclared tyrosine
Nutricia North America is recalling TYR Anamix Early Years infant formula due to undeclared tyrosine. The recall affects 94 cans distributed to 22 states and Puerto Rico.
Product
TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case.
Category
Food
Distribution
22 states
HighFDA (Food)·F-1003-2023·2023-06-28
Frozen Waffles Recalled: Undeclared Soy Lecithin Allergen Risk
Julian's Recipe Maple & Brown Butter Cauli-Wafels are being recalled due to undeclared soy lecithin. The product poses a risk to consumers with soy allergies.
Product
Julian's Recipe Maple & Brown Butter Cauli-Wafels, 7.41 oz.
Category
Food
Distribution
4 states
HighFDA (Food)·F-1001-2023·2023-06-28
FDA Recalls Earth Kratom Red Maeng Da Capsules for Unapproved Additive
Fire Distributors Plus LLC is recalling Earth Kratom Red Maeng Da Kratom capsules because they contain kratom, an unapproved food additive. Approximately 31,600 pouches were distributed in the United States.
Product
EARTH KRATOM RED MAENG DA KRATOM 65 CAPSULES (UPC: 212223242796) (100 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1975-2023·2023-06-28
Serrated Blade Applicator Kit packaging may contain wrong applicator size
Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.
Product
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1979-2023·2023-06-28
Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk
Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V450000·2023-06-28
Kidron Refrigerated Truck Bodies Recalled for Fire Risk
ST Engineering Hackney is recalling 2011-2021 Kidron refrigerated truck bodies because a centrifugal clutch may overheat and break, creating a fire hazard.
Product
KIDRON — KIDRON REFRIGERATED BODIES
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2023·2023-06-28
Hemostatic Clip Device Recalled Due to Deployment Failures
Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.
Product
Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1718-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.
Product
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2023·2023-06-28
Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
Product
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1004-2023·2023-06-28
Julian's Recipe Cauliflower Waffle Sandwiches Recalled for Undeclared Soy Lecithin
Julian's Recipe CAULI-WAFEL SANDWICHES with turkey sausage and cheddar are being recalled because they contain undeclared soy lecithin, which poses a risk to people with soy allergies. The recall affects 1,786 cases distributed in New Jersey, New York, Florida, and Pennsylvania.
Product
Julian's Recipe CAULI-WAFEL SANDWICHES TURKEY SAUSAGE & CHEDDAR,
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1763-2023·2023-06-28
Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2023·2023-06-28
Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures
Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.
Product
Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1985-2023·2023-06-28
Masimo SpO2 Ear Sensor May Produce Inaccurate Oxygen Saturation Readings
Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.
Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1991-2023·2023-06-28
Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions
Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.
Product
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1983-2023·2023-06-28
Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings
Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.
Product
Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1978-2023·2023-06-28
Hemospray Endoscopic Hemostat Recall Due to Endoscope Adhesion Risk
Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.
Product
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1982-2023·2023-06-28
Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
Product
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0999-2023·2023-06-28
Medical Food Product Recalled for Potential Mold Contamination
enterade Advanced Oncology Formula is recalled due to potential mold development and spoilage. The recall affects 43,336 bottles distributed nationwide.
Product
enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after ope
Category
Food
Distribution
47 states
HighFDA (Devices)·Z-1992-2023·2023-06-28
Draeger Resuscitaire Warmer Scale May Display Inaccurate Weight Values
Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.
Product
Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V449000·2023-06-28
2022-2023 BMW I4 Recalled for High Voltage Battery Charging Unit Failure
BMW recalls certain 2022-2023 I4, iX, and i760 models due to a defective high voltage battery charging unit that may not have been properly assembled, potentially causing engine stall while driving.
Product
BMW — BMW IX, I4, 760I
Category
Vehicle
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1000-2023·2023-06-28
Earth Kratom Trainwreck Capsules Recalled for Unapproved Food Additive
Fire Distributors Plus LLC is recalling Earth Kratom Trainwreck capsules because they contain kratom, an unapproved food additive. Consumers should not use these products.
Product
EARTH KRATOM TRAINWRECK 150 CAPSULES (UPC: 908193737324) (50 UNITS/CASE) and 300 CAPSULES (UPC: 005821990011) (25 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules.
Category
Food
Distribution
0 states
ModerateFDA (Drugs)·D-0877-2023·2023-06-28
Glycopyrrolate Tablets Recalled Due to Failed Impurities and Degradation Specifications
Aurolife Pharma has recalled Glycopyrrolate Tablets (1 mg) nationwide due to failed impurity and degradation specifications. Affected lot 01421038A1 expires May 2023.
Product
GLYCOPYRROLATE — GLYCOPYRROLATE (GLYCOPYRROLATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1980-2023·2023-06-28
V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
Product
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2023·2023-06-28
HeartWare Ventricular Assist Device Monitor logfile processing failure
Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.
Product
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1977-2023·2023-06-28
FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability
Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.
Product
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·23V451000·2023-06-27
Lion Electric Recalls 2021-2025 Lion6 and Lion8 Vehicles for Electrical Defect
Lion Electric is recalling 2021-2025 Lion6 and Lion8 vehicles because loose hardware may cause a short circuit, leading to loss of power and increased crash risk.
Product
LION — LION LION6, LION8
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V448000·2023-06-27
Lion LionC School Buses Surge Tank Defect May Cause Steering and Braking Loss
Lion Electric is recalling 2019-2025 LionC school buses due to a surge tank support bracket defect. The tank may crack the firewall and damage high-voltage cables, potentially causing loss of steering assistance, drive power, and braking ability.
Product
LION — LION LIONC
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V447000·2023-06-27
2022-2024 Thor Motor Coach motorhomes recalled for detachable bike racks
Thor Motor Coach is recalling certain 2022-2024 Tranquility and 2022-2023 Sanctuary motorhomes because the R-bike rack arms may fracture and detach, increasing crash risk.
Product
THOR MOTOR COACH — THOR MOTOR COACH TRANQUILITY, SANCTUARY
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23E048000·2023-06-27
Eagle Eyes Recalls Aftermarket Headlights for Peterbilt 389 Vehicles
Eagle Eyes is recalling specific aftermarket headlights for Peterbilt 389 vehicles because they may not provide sufficient light output, potentially reducing visibility and increasing crash risk.
Product
EXTERIOR LIGHTING:HEADLIGHTS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V443000·2023-06-26
Porsche Recalls Macan and Panamera Models for Seat Belt Anchor Defect
Porsche is recalling certain 2016-2020 Macan and Panamera models because a rear seat belt anchor screw may not be tightened properly, increasing injury risk in a crash.
Product
PORSCHE — PORSCHE MACAN S, MACAN, MACAN TURBO, PANAMERA TURBO
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V444000·2023-06-26
Fuel Pump Failure Risk in 2021-2023 Freightliner and Mercedes-Benz Sprinters
Daimler Vans USA is recalling 2021-2023 Freightliner Sprinter and Mercedes-Benz Sprinter and Metris vehicles due to a fuel pump defect. The pump may shutdown, causing loss of drive power and increasing crash risk.
Product
MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER METRIS, SPRINTER 2500, SPRINTER 1500
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V446000·2023-06-26
2022–2023 Porsche 911 GT3 Rear Spoiler Control Software Error
A software error in the rear spoiler control unit may cause brake lights to activate simultaneously on 2022–2023 Porsche 911 GT3 vehicles, potentially confusing other drivers.
Product
PORSCHE — PORSCHE 911 GT3
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V445000·2023-06-26
Mercedes-Benz Fuel Pump May Fail, Causing Loss of Drive Power
Mercedes-Benz USA is recalling certain 2021–2023 vehicles with faulty fuel pumps that may shutdown and cause loss of drive power. Owners should contact dealers for free replacement.
Product
MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 680, S 580, S 580 4MATIC, S 500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V440000·2023-06-23
Ford Recalls 2019-2020 Fusion PHEV Vehicles for Battery Fire Risk
Ford is recalling 2019-2020 Fusion PHEV vehicles because a damaged battery module may cause fire or loss of power.
Product
FORD — FORD FUSION
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·23V442000·2023-06-23
Autocar Recalls 2022-2023 Xspotter Vehicles Due to Fuel Tank Strap Issue
Autocar is recalling 2,671 2022-2023 Xspotter vehicles because fuel tank mounting straps may not be properly secured, increasing crash risk.
Product
AUTOCAR — AUTOCAR XSPOTTER
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V441000·2023-06-23
Volvo Trucks Recall for Loose Steering Gear Fasteners
Volvo Trucks is recalling 2023-2024 VN, VHD, and VAH trucks because steering gear fasteners may not be properly tightened, risking loss of vehicle control. Dealers will tighten the fasteners at no cost to owners.
Product
VOLVO — VOLVO VAH, VHD, VN
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V439000·2023-06-23
2023 Lincoln Nautilus Brake System Risk from Defective Rear Shock Absorbers
Ford is recalling 366 2023 Lincoln Nautilus vehicles due to incorrectly manufactured rear shock absorbers that may damage the brake hose, potentially extending stopping distance and increasing crash risk. Dealers will inspect and replace affected components at no cost.
Product
LINCOLN — LINCOLN NAUTILUS
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·23229·2023-06-22
Zuru Recalls 7.5 Million Baby Shark Bath Toys for Impalement Risk
Zuru is recalling about 7.5 million Robo Alive Junior Baby Shark bath toys due to hard plastic top fins that pose risks of impalement, laceration, and puncture injuries to children. Twelve reported injuries have been documented, including nine cases requiring stitches or medical attention.
Product
Robo Alive Junior Baby Shark Sing & Swim Bath Toys (full-size) and Robo Alive Junior Mini Baby Shark Swimming Bath Toys (mini-size)
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·23E046000·2023-06-22
Lippert Recalls 5200 and 6000 CURT RV Axles Due to Grease Fitting Defect
Lippert is recalling 5200 and 6000 CURT RV axles because improperly tightened grease fittings may separate, potentially causing wheel detachment and increasing crash risk.
Product
SUSPENSION:MULTIPLE AXLE recall
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·23231·2023-06-22
Research Products Steam Humidifiers Recalled for Fire Hazard
Research Products is recalling about 36,200 steam humidifiers with faulty electrode connector wires that can loosen, cause arcing, and overheat. The company has received 103 reports of overheating, including 10 residential fires causing over $10 million in damage.
Product
Steam Humidifiers
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·23V438000·2023-06-22
Altec Recalls 2019-2022 Aerial Devices for Electrical Safety Defect
Altec is recalling 2019-2022 AT335 aerial devices because an inverter-powered outlet may lack ground-fault protection, increasing the risk of injury or fire.
Product
ALTEC — ALTEC AERIAL DEVICE
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·23228·2023-06-22
Boost The Mood Ceramic Mugs Recalled Due to Fire Hazard
Ceramic mugs labeled "microwave safe" can spark and catch fire when microwaved due to metallic print. About 26,400 units were sold at Ulta Beauty stores and online from October 2022 through March 2023.
Product
Boost The Mood Ceramic Mugs
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23230·2023-06-22
Hurtle Multi-Purpose Helmets Recalled Due to Risk of Head Injury
Sound Around is recalling about 1,800 Hurtle multi-purpose children's helmets because they do not meet federal safety standards for positional stability and may fail to protect in a crash.
Product
Hurtle Multi-Purpose Helmet
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23770·2023-06-22
Infanttech Zooby Video Baby Monitors Recalled for Fire Hazard
Infanttech is recalling about 17,100 Zooby video baby monitors for cars because the battery can malfunction, overheat, and burst, posing a fire hazard. The company has received three reports of the monitors catching fire, with no injuries reported.
Product
Zooby video baby monitors for cars
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23769·2023-06-22
Havertys Concord Dual Power Recliner Chairs Fall Hazard Recall
About 930 Havertys Concord Dual Power Recliner Chairs are being recalled because the chair back can detach during use, posing a fall hazard. The firm has received nine reports of detachment, including two with reported injuries to the back, neck, and hip.
Product
Havertys Concord Dual Power Recliner Chairs
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·23227·2023-06-22
Iron Dietary Supplements Recalled Due to Non-Child-Resistant Packaging
Nationwide Pharmaceutical is recalling Ferrous Sulfate enteric-coated tablets because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children. About 4,000 bottles were sold at major retailers from December 2022 through January 2023.
Product
Ferrous Sulfate (Iron) Enteric-Coated Tablets, 324 mg - 100 Tablet Bottles
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·23226·2023-06-22
Poseidon M28A Dive Computers Recalled Due to Water Intake Hazard
Poseidon M28A Dive Computers can stop working when water enters the device, causing the depth sensor to malfunction and loss of dive data. The firm has received one report of water intake but no injuries have been reported.
Product
Poseidon M28A Dive Computers
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0984-2023·2023-06-21
Fresh Organic Strawberries Recalled for Potential Hepatitis A Contamination
Cascade International Foods is recalling approximately 35,686 pounds of Fresh Organic Freezer Strawberries from Mexico distributed in California and Oregon due to potential Hepatitis A contamination.
Product
Fresh Organic Freezer Strawberries Mexico with calyx (caps) removed, net wt. 18 lbs., packaged in a T60-800 Polyethylene Homopolymer picking tray. Product is imported and distributed in fresh condition by Cascade International Foods.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-0985-2023·2023-06-21
Van Leeuwen ice cream recalled for undeclared walnuts
Van Leeuwen brand ice cream may contain undeclared walnuts. Consumers with walnut allergies should not consume this product.
Product
Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM; 14 FL OZ (414 ML); ingredients: cream, milk, dark brown sugar, cane sugar, egg yolks, wheat flour, unbleached flour (wheat flour, malted barley flour), water, cocoa processed with alkali, canola oil
Category
Food
Distribution
10 states

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