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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4526–4550 of 13512

SevereFDA (Devices)·Z-0291-2025·2024-11-20
Philips Trilogy Evo ventilators recall: flow sensor fouling risk
Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.
Product
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0302-2025·2024-11-20
Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were distributed worldwide.
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0305-2025·2024-11-20
Anesthesia workstation piston ventilator may fail before or during use
Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0292-2025·2024-11-20
Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk
Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.
Product
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2025·2024-11-20
Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.
Product
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2025·2024-11-20
Surgical instrument kits recalled due to loose metal flakes
AVID Medical is recalling Halyard Upper Extremity Pack surgical kits because sponge forceps and towel clamps may shed small metal flakes. These flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.
Product
Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2025·2024-11-20
VYGON 100 mL IV Container Pouch Recalled for Potential Leakage
The Metrix Company is recalling a limited number of VYGON 100 mL empty IV containers (Lot Numbers 62040-A8375 and 62040-A8432) due to leakage found during the filling process. The affected containers are distributed in multiple U.S. states and Canada.
Product
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0444-2025·2024-11-20
Halyard IVR Vascular Pack Surgical Instruments Recalled for Loose Metal Components
AVID Medical is recalling Halyard IVR Vascular Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site.
Product
Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0386-2025·2024-11-20
ENT surgical kit recalled for potentially detachable metal flakes in forceps
AVID Medical is recalling Halyard ENT T and A Pack surgical kits nationwide due to loose metal flakes in sponge forceps and towel clamps that may contaminate surgical sites.
Product
Halyard ENT T AND A PACK - Medical convenience kits Model Number: EAMC106-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0448-2025·2024-11-20
Medical Convenience Kits Recalled for Potential Loose Metal Flakes in Surgical Instruments
AVID Medical is recalling Halyard MANIFOLD CATH PACK medical convenience kits because sponge forceps and towel clamps may shed metal flakes that could contaminate surgical sites.
Product
Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0447-2025·2024-11-20
Halyard Angiography Drape Pack Recalled for Potential Metal Flakes in Surgical Site
AVID Medical recalls Halyard angiography drape packs due to potential metal flakes that could detach from sponge forceps and towel clamps. These flakes could enter a surgical site undetected and cause local or foreign body reactions.
Product
Halyard ANGIOGRAPHY DRAPE PACK - Medical convenience kits Model Number: VMCC021-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0442-2025·2024-11-20
Halyard Pacemaker Instrument Packs Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard Pacemaker Instrument Packs (Model VAPX040-01) because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site during procedures.
Product
Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: VAPX040-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0425-2025·2024-11-20
Halyard Urology Laparotomy Pack surgical instruments recalled for detachable metal flakes
AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.
Product
Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2025·2024-11-20
Stryker smoke evacuation pencil recall: unintended activation risk
Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.
Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation sys
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0434-2025·2024-11-20
Surgical instrument kits recalled for loose metal flakes
AVID Medical is recalling Halyard CPT EP PACK surgical convenience kits due to loose metal flakes on forceps and towel clamps. Detached metal flakes could enter surgical sites and potentially cause local tissue reactions or foreign body complications.
Product
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0369-2025·2024-11-20
Stryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation
Stryker Corporation is recalling 21,490 Neptune SafeAir Smoke Evacuation Pencils due to risk of unintended activation that could cause electrical burns. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0389-2025·2024-11-20
Surgical Instruments Recalled for Loose Metal Flakes in Set-Up Packs
AVID Medical is recalling Halyard GENERAL SET UP PACK medical convenience kits nationwide due to sponge forceps and towel clamps that may shed small metal flakes into patients' surgical sites, risking local reactions and foreign body reactions.
Product
Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0355-2025·2024-11-20
Medical Laboratory Kit Recalled Due to Non-Sterile Specimen Container
Medline Industries is recalling over 626,000 laboratory kits because the included specimen container is labeled as sterile but is actually non-sterile. Non-sterile containers risk sample contamination and may result in unnecessary treatment or prolonged hospitalization.
Product
Lab Kit, SKU DYLAB1018; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2025·2024-11-20
Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2025·2024-11-20
IV Fluid Container Bags Recalled for Potential Leaks During Filling
The Metrix Company is recalling SECURE 250 mL IV fluid containers due to leaks found during filling. Affected units were distributed nationwide and to Canada.
Product
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2025·2024-11-20
Halyard Vaginal Gyn Pack Recalled Due to Loose Metal Flakes Risk
AVID Medical is recalling the Halyard MAJOR VAGINAL GYN PACK due to sponge forceps and towel clamps that may shed loose metal flakes. These flakes could enter a surgical site undetected, causing local reactions or foreign body reactions.
Product
Halyard MAJOR VAGINAL GYN PACK - Medical convenience kits Model Number: SAMM021-11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2025·2024-11-20
Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness
Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.
Product
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0454-2025·2024-11-20
Medical convenience kits recalled due to detachable metal flakes
AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2025·2024-11-20
Cystoscope Outer Sheath Recalled for Potential Laser Probe Damage
Olympus is recalling 738 units of the WA22810A Cystoscope Outer Sheath distributed nationwide due to potential damage to the laser probe tip during use with GreenLight Laser for BPH therapy. The manufacturer removed this compatibility claim from product instructions.
Product
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2025·2024-11-20
IV Fluid Container Bags Recalled for Leaking Defect
The Metrix Company is recalling SECURE 100 mL empty EVA containers for IV use due to leaking discovered during filling. Approximately 2,229 cases were distributed to healthcare facilities in the US and Canada.
Product
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide

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4526–4550 of 13512