Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

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76–100 of 390

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-2172-2026·2026-05-20
Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
Product
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2155-2026·2026-05-20
Revolution Apex Select CT systems subject to software security vulnerability recall
GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.
Product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
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-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-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-2190-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2171-2026·2026-05-20
ZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.
Product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
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-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-2134-2026·2026-05-20
DonJoy IceMan Classic Cube cold therapy unit connector defect recall
DJO, LLC is recalling DONJOY ICEMAN CLASSIC CUBE cold therapy units due to broken connectors that may interrupt prescribed cold therapy. Approximately 596 units were distributed nationwide and in Canada.
Product
Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps pro
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-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 (Devices)·Z-2135-2026·2026-05-20
DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect
DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.
Product
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
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
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
SevereFDA (Devices)·Z-2007-2026·2026-05-13
Medical Action Industries Pack Cath BHH Catheter Kit Recall
Medical Action Industries is recalling Pack Cath BHH catheter kits because the rotating adapter may unwind during use, causing a loose or full disconnection between the syringe and manifold.
Product
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case
Category
Medical Device
Distribution
1 state
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 (Devices)·Z-2091-2026·2026-05-13
Medline Convenience Kits Recalled for Sterilization Calibration Issues
Medline is recalling multiple convenience kits used in catheterization labs and surgical procedures due to calibration issues with sterilization equipment that may affect sterility assurance. The affected kits were distributed nationwide.
Product
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRINGE, Model Number:DYKE1743; 3) BGMC ANGIOGRAPHY PACK-LF, Model Number:DYNJ0800934D; 4) GENERAL ENDO PACK-LF, Model Number:DYNJ0842873J; 5) ANGIO PROCEDURE PACK, Model Number:DY
Category
Medical Device
Distribution
Distributed nationwide
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 (Devices)·Z-1978-2026·2026-05-13
Halyard SAMMC Angiography Kit syringe rotating adapter unwinding recall
Halyard SAMMC ANGIOGRAPHY kits (Model SAMM066-15) are recalled because the Medline syringe rotating adapter may unwind during use, causing a loose or disconnected connection between the syringe and manifold. 2,392 kits were distributed across US states including FL, IL, MO, MS, NC, NE, and TX.
Product
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1942-2026·2026-05-13
VOCSN V+Pro Ventilator System Respiratory Device Safety Recall
Ventec Life Systems is recalling VOCSN V+Pro ventilator units because they may not have been fully tested for high-pressure conditions, which could cause oxygen leaks and increase fire risk during use.
Product
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2108-2026·2026-05-13
Medline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
Medline Industries is recalling approximately 29,192 labor and delivery kits and OB packs due to calibration issues in sterilization equipment that may impact sterility assurance. The products were exposed to validated sterilization cycles, but the calibration problems potentially compromise sterile status.
Product
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) KIT LABOR & DELIVERY CERCL
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2106-2026·2026-05-13
Medline Convenience Kits recalled due to sterilization equipment calibration issues
Medline Industries is recalling four Convenience Kit models (892 units) nationwide because sterilization and packaging equipment calibration issues may have compromised the sterility assurance level of the devices.
Product
Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST-LF, Model Number: DYNJ83950; 3) HERNIA REPAIR TOTE, Model Number: DYNJ908337A; 4) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
Category
Medical Device
Distribution
Distributed nationwide

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