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

5251–5275 of 40007

HighFDA (Devices)·Z-0487-2025·2024-11-27
Ethicon Recalls Monocryl Sutures Due to Component Mix-Up
Ethicon, Inc. is recalling 16,524 units of Monocryl sutures because a manufacturing error may result in incorrect needle types, sizes, or suture lengths.
Product
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-0484-2025·2024-11-27
Maquet Cardiovascular Recalls Acrobat-i Positioners Due to Sterility Concerns
Maquet Cardiovascular is recalling 14,338 Acrobat-i Positioners because manufacturing deviations compromised the sterile barrier, meaning sterility cannot be assured during the product's 2-year shelf life.
Product
Acrobat-i Positioner. Model Number C-XP-5000Z
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0501-2025·2024-11-27
OrganOx metra Liver Perfusion System Recalled for Battery Damage
OrganOx Ltd is recalling 20 metra liver perfusion systems because battery movement caused a cell to short against the retention bracket.
Product
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-0490-2025·2024-11-27
Alcon anti-reflux valve tubing breakage recall due to improper use
Alcon Research LLC is recalling its Custom-Pak anti-reflux valve tubing because breakage occurred from improper use, resulting in updated labeling requirements.
Product
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0500-2025·2024-11-27
Precice Max Orthopedic Implants Recalled for Design and Manufacturing Validation Issues
NuVasive Specialized Orthopedics is recalling 164 Precice Max orthopedic implants distributed to Florida and Nevada due to potential design, manufacturing, and documentation validation issues.
Product
Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm PM10.0-80B335 PREC
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0498-2025·2024-11-27
Olympus Gastrointestinal Videoscope Drying Instructions Clarified
Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.
Product
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentati
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0310-2025·2024-11-20
Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0303-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Product
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0304-2025·2024-11-20
Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
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-0293-2025·2024-11-20
Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.
Product
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
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
SevereFDA (Devices)·Z-0296-2025·2024-11-20
Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure
Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.
Product
LifeVent EVO2. Model Number: SP2100X26B. 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-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-0357-2025·2024-11-20
Medline Recalls Non-Sterile Urinalysis Kit Specimen Containers
Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or hospitalization.
Product
URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0404-2025·2024-11-20
AVID Medical Recalls Halyard Laparoscopy Trays Due to Metal Flakes
AVID Medical is recalling 42 Halyard Laparoscopy Trays because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0406-2025·2024-11-20
AVID Medical Recalls Halyard C Section Bundles Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard C Section Bundles because small metal flakes may detach from sponge forceps and towel clamps, posing a risk of foreign body reactions.
Product
Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34
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-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-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-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-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-0298-2025·2024-11-20
FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.
Product
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Category
Medical Device
Distribution
0 states

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5251–5275 of 40007