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 13526

SevereFDA (Devices)·Z-0312-2025·2024-11-20
FHC microTargeting Insertion Tube Set Recalled for Spacer Defect
FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.
Product
microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0300-2025·2024-11-20
Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk
Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.
Product
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0301-2025·2024-11-20
Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk
Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
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-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-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-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-0290-2025·2024-11-20
Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction
Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.
Product
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2025·2024-11-20
Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk
Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.
Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, 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 system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0387-2025·2024-11-20
Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments
AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.
Product
Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
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-0388-2025·2024-11-20
Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
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-0332-2025·2024-11-20
IV Fluid Containers Recalled for Leakage Risk During Filling
The Metrix Company is recalling CORMIX 150 mL empty IV fluid containers due to leakage found during filling, which could compromise the integrity of intravenous fluids.
Product
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; 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-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-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-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
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-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-0462-2025·2024-11-20
MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage
The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0464-2025·2024-11-20
IMMULITE 2000 PSA assay does not meet high-dose analytical performance claim
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
Product
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0412-2025·2024-11-20
Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes
AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.
Product
Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2025·2024-11-20
Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.
Product
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2025·2024-11-20
Halyard Lower Extremity Pack surgical kits recalled for loose metal fragments
AVID Medical is recalling Halyard Lower Extremity Pack surgical kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site undetected, potentially causing local or foreign body reactions.
Product
Halyard LOWER EXTREMITY PACK - Medical convenience kits Model Number: PANJ001-03
Category
Medical Device
Distribution
Distributed nationwide

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