FDA Recalls

The latest food, drug and medical device recalls reported by the U.S. Food and Drug Administration, newest first. Data updated Oct 21, 2026.

87,918 recalls · page 14 of 30

Class IIDeviceOngoing
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Philips North America Llc · Cambridge, MA

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Class IIDeviceOngoing
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Maquet SAS · Orleans Cedex 2
Class IIDeviceOngoing
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Class IIDeviceOngoing
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Philips North America Llc · Cambridge, MA
Class IIDeviceOngoing
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.
Olympus Corporation of the Americas · Center Valley, PA
Class IIDeviceOngoing
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724
Class IIDeviceOngoing
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound, LLC · Bothell, WA
Class IIDeviceOngoing
SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
SEASPINE ORTHOPEDICS CORPORATION · Carlsbad, CA
Class IDeviceOngoing
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Class IIDeviceOngoing
Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A; 6) NEURO PACK, Catalog Number: DYNJ86656; 7) NEURO ACD, Catalog Number: DYNJ904549G
Class IIDeviceOngoing
Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01
AVID Medical, Inc. · Toano, VA
Class IIDeviceOngoing
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
Class IIDeviceOngoing
Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
Medline Industries, LP · Northfield, IL
Class IIDeviceOngoing
HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post Valve
Ventec Life Systems, Inc. · Bothell, WA
Class IIDeviceOngoing
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Philips North America Llc · Cambridge, MA
Class IIDeviceOngoing
ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight oximeter cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
Class IIDeviceOngoing
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Baxter Healthcare Corporation · Deerfield, IL
Class IIDeviceOngoing
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08
Class IIDeviceOngoing
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A13
Class IIDeviceOngoing
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T
Class IIDeviceOngoing
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
Class IIDeviceOngoing
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to Ingenia Elition X; Model Numbers (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782145 (3.0T), 5. 781270 (XR and 3.0T), 6. 782113 (XR and 3.0T), 7. 782129 (XR and 3.0T), 8. 782118 (Ingenia Elition X), 9. 782144 (Ingenia Elition X);
Class IIDeviceOngoing
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219
Class IIDeviceOngoing
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries, LP · Northfield, IL
Class IFoodOngoing
Everything Sprouts Crunchy Protein Sprout Mix, containing Alfalfa Fenugreek, Cabbage, Mung, Adzuki, Lentils, Green Pea, Net Wt. 5.0 oz (142 g) UPC 0 87906-01018 7. everythingsprouts.com
Class IFoodOngoing
Tomato Salsa Fresca. Ingredients: Tomatoes, Yellow Onion, Red Onion, Cilantro, Jalapeno Pepper, Garlic, Salt, Ground Cumin, Lemon Juice. Net Wt: 4 lbs. Keep Refrigerated.
Class IFoodOngoing
PICO DE GALLO-HOT-6/9oz HEB-PICO-HOT-12/14oz
NatureBest Pre-Cut & Produce LLc · Missouri City, TX
Class IIIFoodOngoing
Hexing Haw Balls candy; packaged in 200g/0.44 lb./7.05 oz clear plastic bag; Ingredients: haw, white sugar, water.; Serving suggestion: ready to eat. Storage: keep in cool and dry place and keep tightly closed in refrigerator after opening.; PRODUCT OF CHINA; UPC 6 920603 810025
Class IFoodOngoing
Pico De Gallo. Ingredients: Tomato, Onion, Jalapeno Pepper, Cilantro, Garlic, Salt, Black Pepper. Net Wt: 7 oz. Keep Refrigerated. Distributed By: ADUSA Distribution, LLC, Salisbury, NC 28147. UPC: 688267575778
Class IFoodOngoing
Pineapple Mango Salsa Mild. Ingredients: Mango, Pineapple, Pasteurized Lime Juice, Pasteurized Lemon Juice, Jalapeno Pepper, Serrano Pepper, Lime Flavored Zest (***), Lemon Peel (***), Spearmint, Salt. Net Wt: 10 oz. Keep Refrigerated. Distributed By: Taylor Farms Inc., Salinas, CA 93902. UPC: 030223075653
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Source: openFDA enforcement reports. Not for medical decisions; data may be incomplete or unvalidated.

Reported Sep 30, 2026 · Z-3235-2026

The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Reported Sep 30, 2026 · Z-3224-2026

Cardinal Health 200, LLC · Waukegan, IL

The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.

Reported Sep 30, 2026 · Z-3255-2026

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Reported Sep 30, 2026 · Z-3238-2026

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

Reported Sep 30, 2026 · Z-3245-2026

Midmark Corporation · Versailles, OH

A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.

Reported Sep 30, 2026 · Z-3220-2026

Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.

Reported Sep 30, 2026 · Z-3249-2026

The proximal thread depth of the spinal device is out of design specification.

Reported Sep 30, 2026 · Z-3226-2026

CooperSurgical, Inc. · Trumbull, CT

Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

Reported Sep 30, 2026 · Z-3139-2026

Medline Industries, LP · Northfield, IL

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Reported Sep 30, 2026 · Z-3268-2026

Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.

Reported Sep 30, 2026 · Z-3261-2026

Philips North America Llc · Cambridge, MA

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Reported Sep 30, 2026 · Z-3240-2026

Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.

Reported Sep 30, 2026 · Z-3230-2026

Labeling; Oxygen Cylinders do not contain required medical gas labeling

Reported Sep 30, 2026 · Z-3221-2026

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Reported Sep 30, 2026 · Z-3237-2026

Becton, Dickinson and Company · Irvine, CA

Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables.

Reported Sep 30, 2026 · Z-3250-2026

Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

Reported Sep 30, 2026 · Z-3257-2026

Baxter Healthcare Corporation · Deerfield, IL

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Reported Sep 30, 2026 · Z-3262-2026

Baxter Healthcare Corporation · Deerfield, IL

There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.

Reported Sep 30, 2026 · Z-3263-2026

Medline Industries, LP · Northfield, IL

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Reported Sep 30, 2026 · Z-3267-2026

Philips North America Llc · Cambridge, MA

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Reported Sep 30, 2026 · Z-3232-2026

Philips North America Llc · Cambridge, MA

A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

Reported Sep 30, 2026 · Z-3243-2026

Medline Industries, LP · Northfield, IL

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Reported Sep 30, 2026 · Z-3265-2026

The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Reported Sep 30, 2026 · Z-3266-2026

Everything Sprouts, LLC · Minneapolis, MN

Sprouts may be contaminated with STEC E. coli and/or Salmonella.

Reported Sep 23, 2026 · H-1339-2026

Taylor Fresh Foods Inc · Salinas, CA

Potential contamination with Salmonella.

Reported Sep 23, 2026 · H-1364-2026

Jalapenos have the potential to be contaminated with Salmonella

Reported Sep 23, 2026 · H-1379-2026

Tiffany Food Corp · Brooklyn, NY

Unapproved dye Ponceau 4R

Reported Sep 23, 2026 · H-1387-2026

Taylor Fresh Foods Inc · Salinas, CA

Potential contamination with Salmonella.

Reported Sep 23, 2026 · H-1355-2026

Taylor Fresh Foods Inc · Salinas, CA

Potential contamination with Salmonella.

Reported Sep 23, 2026 · H-1354-2026