The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

176–200 of 633

  • ModerateFDA (Devices)·Z-2161-2026·2026-05-20

    LUCAS Chest Compression Systems Recalled for Inadequate Service Documentation

    Jolife AB is recalling 153 LUCAS chest compression systems (Models 2, 3, and 3.1) due to incomplete service documentation. Service work performed on affected systems was not properly documented in service records.

    Product
    LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 0088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0777-2026·2026-05-20

    Swad Orange Flavored Masala Candy recalled for undeclared FD&C Yellow 6

    Raja Foods and Vegetables Inc. is recalling Swad Orange Flavored Masala Candy because it contains undeclared FD&C Yellow 6, which may pose a risk to consumers with sensitivities to this food coloring.

    Product
    Swad Orange Flavored Masala Candy
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2154-2026·2026-05-20

    Revolution Apex X-ray CT System Security Vulnerability Recall

    GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.

    Product
    Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2026·2026-05-20

    Hologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall

    Hologic is recalling certain 3DIMENSIONS MAMMOGRAPHY SYSTEM models due to internal bolts that may become loose, missing, or broken over time. The FDA classified this as a Class II recall.

    Product
    3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall

    Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.

    Product
    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2026·2026-05-20

    Thermedx FluidSmart Urology Tube Set recalled for nonconforming products

    Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.

    Product
    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2026·2026-05-20

    Philips Azurion X-Ray System Cable Hose Carriers May Loosen or Break

    Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.

    Product
    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2026·2026-05-20

    Diowave Laser System Software Update Required for Power Output Issue

    Diowave 250W Laser Systems require a software update because some units operate at up to 70W maximum average power output, exceeding the FDA-cleared limit of 60W.

    Product
    Diowave Laser System, REF: Diowave 250W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2151-2026·2026-05-20

    Revolution Apex Elite X-ray CT System Security Vulnerability Recall

    GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.

    Product
    Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2136-2026·2026-05-20

    DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Fault Recall

    DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (Model 11-1424) due to a broken connector that may interrupt prescribed cold therapy treatment.

    Product
    Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2026·2026-05-20

    Revolution CT X-ray Computed Tomography System Security Vulnerability Recall

    GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.

    Product
    Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2173-2026·2026-05-20

    Codman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin

    Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.

    Product
    Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2026·2026-05-20

    Buprenorphine Hydrochloride Injection Recall Due to Particulate Matter

    Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2026·2026-05-20

    Revolution Apex Plus CT System Security Vulnerability Recall

    GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected worldwide.

    Product
    Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2149-2026·2026-05-20

    Revolution Ascend CT scanner security vulnerability affecting AW Server

    GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.

    Product
    Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0770-2026·2026-05-20

    Dakota Honey Company Spreadable Spun Honey Salted Caramel Recall

    Dakota Honey Company is recalling Spreadable Spun Honey, Salted Caramel, in 4 oz and 12 oz jars due to possible presence of foreign objects including stainless steel dust, flakes, or plastic shreds.

    Product
    Dakota Honey Company Spreadable Spun Honey, Salted Caramel. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41981 4. 2. Net Wt 12 oz (340g) UPC 8 60010-57964 0.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0512-2026·2026-05-15

    Sliced Deli Turkey Recalled Nationwide Over Listeria Risk

    Northfield Foods is recalling 187,000 lbs of sliced deli turkey after Listeria was found during routine testing.

    Product
    Northfield Select — Oven-Roasted Sliced Turkey Breast
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1935-2026·2026-05-13

    Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk

    Cook Incorporated is recalling Aurous Centimeter Sizing Catheters due to risk of marker band cracking or breakage during angiographic procedures. Potential complications include device fragmentation, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1934-2026·2026-05-13

    Cook Centimeter Sizing Catheter recall due to marker band cracking

    Cook Incorporated is recalling Centimeter Sizing Catheters because marker bands may crack or break, potentially causing device fragmentation, vessel injury, or life-threatening harm.

    Product
    Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1977-2026·2026-05-13

    Halyard PERC TRAY Kit Syringe Adaptor Connection Risk Recall

    The Halyard PERC TRAY kit (models SLPC34-01 and SLPC34-02) is being recalled due to risk that a Medline syringe rotating adaptor may unwind during use, causing a loose or full disconnection between the syringe and manifold.

    Product
    Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·H-0837-2026·2026-05-13

    Bulk WN-976-782-1 Seasoning for Cheese Sauce Salmonella Contamination

    Givaudan Flavors Corp is recalling Bulk WN-976-782-1 Seasoning for Cheese Sauce due to potential Salmonella contamination. The affected product is a 43.50 lb. bulk seasoning in a brown kraft bag.

    Product
    Bulk WN-976-782-1 Seasoning for Cheese Sauce, Net Wt. 43.50 lbs., in a brown kraft bag
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1936-2026·2026-05-13

    Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands

    Cook Incorporated is recalling Beacon Tip Centimeter Sizing Catheters because marker bands may crack or break, which could lead to device fragmentation, prolonged procedures, vessel injury, and in worst-case scenarios, life-threatening harm or death.

    Product
    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0762-2026·2026-05-13

    Raw Farm Raw Cheddar Cheese Recalled for E. coli O157:H7 Contamination

    Raw Farm Raw Cheddar cheese in 8 oz and 16 oz packages is recalled due to a multi-state E. coli O157:H7 outbreak. Affected products were distributed in nine U.S. states.

    Product
    RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (4
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0523-2026·2026-05-13

    Naproxen Oral Suspension Recalled for Lead and Lithium Contamination

    Acella Pharmaceuticals is recalling Naproxen oral suspension due to the presence of lead and lithium above specification levels. The recall affects 6,336 bottles distributed nationwide.

    Product
    NAPROXEN — NAPROXEN (NAPROXEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2062-2026·2026-05-13

    ERBEFLO CleverCap CO2 Tubing and Cap Sets for Endoscopes

    Erbe Medical is recalling ERBEFLO CleverCap CO2 hybrid tubing and cap sets used with endoscopes because the distal connector may allow unintended water flow, potentially leading to water aspiration and serious respiratory complications.

    Product
    ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; Hybrid CO2 Tubing/Cap Set for Olympus Scopes & UCR, REF: 20325-240; Hybrid CO2 Tubing/Cap Set for Olympus Scopes, REF: 20325-206; Hybrid CO2 Tubing/Cap Set for Pentax Scopes, REF: 2
    Category
    Medical Device
    Distribution
    Distributed nationwide