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

3776–3800 of 27375

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-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-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-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-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
SevereFDA (Devices)·Z-0297-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.
Product
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Category
Medical Device
Distribution
0 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
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-0327-2025·2024-11-20
Baxter AK 98 Dialysis Machine Recalled for Potential Chemical Exposure
Baxter is recalling AK 98 Dialysis Machines due to potential exposure to polychlorinated biphenyl acids and polychlorinated biphenyls.
Product
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
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-0341-2025·2024-11-20
Metrix SECURE 1000 mL IV Container Recall Due to Leaking
The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.
Product
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; 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-0429-2025·2024-11-20
AVID Medical Recalls Pacemaker Convenience Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard SAMMC-N pacemaker convenience kits because sponge forceps and towel clamps may shed metal flakes that could enter a patient's surgical site.
Product
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0432-2025·2024-11-20
AVID Medical Recalls Halyard CPT PEDS ADULT CH PACK Surgical Kits
AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.
Product
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0403-2025·2024-11-20
AVID Medical Recalls Halyard MINOR PDS Medical Convenience Kits
AVID Medical, Inc. is recalling 137 Halyard MINOR PDS medical convenience kits because sponge forceps and towel clamps may release metal flakes into surgical sites.
Product
Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2025·2024-11-20
AVID Medical Recalls Halyard Line Insertion Packs Due to Metal Flakes
AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
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-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-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-0439-2025·2024-11-20
AVID Medical Recalls Halyard EP PACK Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard EP PACK - Medical convenience kits Model Number: VANW018-06
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-0445-2025·2024-11-20
AVID Medical Recalls Halyard Surgical Kits Due to Metal Flakes
AVID Medical is recalling Halyard SPECIALS PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2025·2024-11-20
Medtronic Recharger Kits Recalled for Potential Failure to Initiate Recharging
Medtronic is recalling 118 wireless recharger kits for implantable neurostimulators because they may fail to start a recharging session upon first use.
Product
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Bra
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-0418-2025·2024-11-20
AVID Medical Recalls Heart Cath Lab Kits Due to Metal Flakes
AVID Medical is recalling 411 Heart Cath Lab Kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
Category
Medical Device
Distribution
Distributed nationwide

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3776–3800 of 27375