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

3551–3575 of 13449

HighFDA (Devices)·Z-1399-2025·2025-03-26
VERICIS Merge Cardio may display inconsistent measurement data in clinical reports
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1365-2025·2025-03-26
Sterile Surgical Drape Recalled Due to Potential Packaging Breach
Medline Industries is recalling 114 units of Proxima Drape surgical drapes due to a potential breach in pouch packaging that could compromise sterility. Affected units were distributed nationwide.
Product
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2025·2025-03-26
Sterile surgical drapes recalled due to potential packaging breach
Medline Industries is recalling 220 Proxima Drape sterile surgical drapes nationwide due to a potential breach in pouch packaging that could compromise sterility.
Product
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1349-2025·2025-03-26
Laceration Trays Recalled Due to Sterility Assurance Concerns
American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.
Product
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1375-2025·2025-03-26
BD Pyxis Medication Dispensing Systems Software Sync Error Recall
BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.
Product
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2025·2025-03-26
Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.
Product
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2025·2025-03-26
CAPNOCHECK BCI Airway Adapter may break off, causing ventilation failure
The CAPNOCHECK BCI Airway Adapter (Model BSR) may break when attached to a valve or tube, risking airway circuit failure and loss of ventilation. Approximately 175,994 units were recalled nationwide.
Product
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1398-2025·2025-03-26
VERICIS Merge Cardio Cardiovascular System Software Recall for Measurement Inconsistency
Merge Healthcare's VERICIS Merge Cardio software (versions 9.0.6 and 9.0.8) may produce measurement inconsistencies under specific workflows. Derived measurements may not match primitive measurements in final patient reports.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1362-2025·2025-03-26
Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance
American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.
Product
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1363-2025·2025-03-26
Medline Proxima sterile surgical drapes recalled due to potential packaging breach
Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.
Product
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1393-2025·2025-03-26
Medline C-Section Procedure Kits Recalled for Defective Syringes
Medline is recalling 456 C-section procedure kits containing plastic syringes affected by an FDA safety alert. The syringes may leak or break, posing a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1358-2025·2025-03-26
Vascular Pack Sterilization Assurance Requirements Cannot Be Confirmed
American Contract Systems cannot confirm Major Vascular Pack surgical kits were properly sterilized. Sterilization assurance failure could result in loss of functionality and delayed patient treatment.
Product
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2025·2025-03-26
AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
Product
AV FISTULA , Model No UTAV77T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1370-2025·2025-03-26
Surgical drapes recalled due to potential sterility breach in packaging
Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.
Product
Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2025·2025-03-26
Microstream CO2 sampling lines recalled for difficult adapter disconnection
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2025·2025-03-26
Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2025·2025-03-26
Proxima Drape sterile drapes recalled for potential packaging breach risk
Medline Industries is recalling Proxima Drape sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. The recall affects 2,422 units distributed nationwide.
Product
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2025·2025-03-26
VERICIS Merge Cardio Medical Device Software Measurement Data Consistency Issue
VERICIS Merge Cardio cardiovascular imaging software may display measurement values in patient reports that do not match original measurements when measurements are remeasured or manually edited. This affects 66 units distributed in the United States.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1; The VERICIS is an integrated cardiovascular information system classified as a picture archiving and communications system.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1339-2025·2025-03-26
Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.
Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2025·2025-03-26
Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
Product
CV BASIC PUMP PACK , Model No WECV23D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1385-2025·2025-03-26
Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance Neonatal-Infan
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2025·2025-03-26
Medical Device Software May Merge Patient Records Without Notification
Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.
Product
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1383-2025·2025-03-26
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2025·2025-03-26
Medical Device HIP SCOPE Recall Due to Sterilization Assurance Failure
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
Product
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Category
Medical Device
Distribution
Distributed nationwide

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3551–3575 of 13449