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

8176–8200 of 27635

HighFDA (Devices)·Z-1402-2025·2025-03-26
Merge Cardio Software Recalled: Measurement Inconsistency in Patient Reports
Merge Healthcare recalls Merge Cardio cardiovascular software due to measurement data inconsistency. When users manually edit or remeasure values in certain workflows, derived measurements may not match original measurements in patient reports.
Product
Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.1, 12.1.1, 12.2, 12.3, 12.3.1, 12.3.2, 12.3.3, 12.4, 12.4.1, 12.4.2; Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system.
Category
Medical Device
Distribution
0 states
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 (Drugs)·D-0291-2025·2025-03-26
FDA Recalls Super-Potent Levothyroxine Sodium Tablets Due to Potency Deviation
Mylan Institutional is recalling 1,068 cartons of levothyroxine sodium 125 mcg tablets (Lot 3115773) distributed nationwide due to out-of-specification potency. The tablets contain higher-than-specified amounts, potentially resulting in excessive doses.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2025·2025-03-26
Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.
Product
BORN ON ARRIVAL KIT , Model No LLBN11B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1407-2025·2025-03-26
Synapse PACS Software incorrect patient age calculation for infants
FUJIFILM's Synapse PACS Software versions 7.4.x incorrectly calculates patient age for infants under 3 months, potentially affecting clinical decisions. 104 units recalled in US and internationally.
Product
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
Category
Medical Device
Distribution
30 states
HighFDA (Devices)·Z-1401-2025·2025-03-26
Cardiovascular Information System Measurement Inconsistency in Merge Cardio
Merge Healthcare's VERICIS Merge Cardio cardiovascular information system may display inconsistent measurements under specific workflows involving ultrasound remeasurement or manual measurement editing. No illnesses have been reported.
Product
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; 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-1347-2025·2025-03-26
Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns
American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.
Product
TOTAL HIP PACK , Model No SMTH06O SMTH06P
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-1376-2025·2025-03-26
CO2 Sampling Lines May Fail to Disconnect During Neonatal Care
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended extubation. The defect affects neonatal and pediatric patients worldwide.
Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine H Set & VitaLine H Set Infant/Neonatal, 006147 - MICROSTREAM FilterLine H Set Infant/Neonatal CO2 Sampling Line and Airway Adapter for Humid Environments, 006324; MICROSTREAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0644-2025·2025-03-26
HOT ONES Verde hot sauce recalled for possible plastic contamination
HOT ONES brand VERDE hot sauce by Heatonist is being recalled due to possible plastic foreign object contamination. Multiple sizes were distributed in North Carolina, Ohio, Indiana, and Illinois.
Product
HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST; 1 gallon, 5 oz, and 5 gallon sizes; UPC: 8-51444-00803-5
Category
Food
Distribution
4 states
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-1366-2025·2025-03-26
Proxima Drape surgical drapes recalled due to potential sterility loss
Medline Industries recalls 506 units of Proxima Drape surgical drapes nationwide due to potential packaging breaches that could compromise sterility. Affected drapes were labeled as MINOR PACK or LAPAROSCOPY variants.
Product
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0290-2025·2025-03-26
Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency
Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2025·2025-03-26
Candida ID Antigen recalled for reduced sensitivity, potential false negatives
Immuno-Mycologics' Candida ID Antigen may have reduced sensitivity, causing false negative diagnostic results. Lot F4171005 has been distributed worldwide including CA and OK.
Product
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in the ID test, RX only, IVD, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1397-2025·2025-03-26
IV Catheter Valve Housing May Detach and Cause Leakage
B. Braun Medical is recalling Introcan Safety 3 IV catheters because the valve housing may detach, causing fluid leakage. Approximately 28,200 units are affected.
Product
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Category
Medical Device
Distribution
16 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-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 (Food)·F-0642-2025·2025-03-26
emd Oysterettes Oyster Crackers Recalled for Metal Contamination
Dairy State Foods Inc is recalling emd Oysterettes oyster crackers due to the possibility of metal contamination. Affected batches have date codes 34824 and 35324 and were distributed in Michigan.
Product
emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212.
Category
Food
Distribution
1 state
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 (Drugs)·D-0280-2025·2025-03-26
Prasugrel 5 mg Tablets Recalled Due to Failed Dissolution Specifications
Mylan Pharmaceuticals is recalling specific lots of Prasugrel 5 mg tablets due to failed dissolution specifications. The affected tablets may not dissolve properly in the body.
Product
PRASUGREL — PRASUGREL (PRASUGREL)
Category
Drug
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
SevereCPSC·25187·2025-03-20
Aiper Seagull Pro Cordless Pool Cleaners Recalled for Fire and Burn Hazards
About 32,660 Aiper Seagull Pro pool cleaners are recalled because the power adapter can overheat and catch fire. The firm reported 19 incidents of melting, smoking or fires, resulting in 5 property damage claims with no injuries.
Product
Aiper Seagull Pro ZT6001 cordless robotic pool cleaners
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·25188·2025-03-20
Model Year 2025 Ski-Doo and Lynx Snowmobiles Recalled for Engine Mount Failure
Bombardier Recreational Products recalls about 4,144 Model Year 2025 Ski-Doo and Lynx snowmobiles due to engine control module mounts that may break and cause stuck throttle, creating a crash hazard.
Product
Model Year 2025 Ski-Doo and Lynx snowmobiles equipped with a 600R E-TEC, 850 E-TEC or 850 E-TEC Turbo R engine
Category
Vehicle
Distribution
Distributed nationwide

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8176–8200 of 27635