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

801–825 of 5027

SevereFDA (Devices)·Z-0659-2025·2024-12-25
Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk
Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.
Product
Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0654-2025·2024-12-25
Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure
Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.
Product
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0328-2025·2024-12-04
Hologic BioZorb Radiographic Marker Recalled Due to Serious Injury Reports
Hologic has recalled 12,710 BioZorb Markers nationwide after receiving reports of serious complications including infection, device migration, and device erosion. The FDA classified this as a Class I recall.
Product
BioZorb Marker. Radiographic soft tissue marker.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0382-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0378-2025·2024-11-27
Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure
Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult their healthcare provider.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0379-2025·2024-11-27
Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk
Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0373-2025·2024-11-27
Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk
Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0377-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk
Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0482-2025·2024-11-27
Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems
Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.
Product
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0375-2025·2024-11-27
Baxter peritoneal dialysis transfer set recalled for PCB exposure risk
Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
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-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
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
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-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-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-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
SevereFDA (Devices)·Z-0295-2025·2024-11-20
Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.
Product
Garbin Evo. Model Number: LD2110X23B. 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-0299-2025·2024-11-20
Cryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk
Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.
Product
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Category
Medical Device
Distribution
0 states
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-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-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

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801–825 of 5027