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

376–400 of 36488

SevereFDA (Devices)·Z-2551-2026·2026-07-08
Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
Product
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0643-2026·2026-07-08
ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2621-2026·2026-07-08
Preop Kit-NS surgical kits recalled for bacterial contamination
A M S Preop Kit-NS surgical convenience kits are being recalled due to contamination with Paenibacillus phoenicis bacteria discovered during sterilization testing. The kits were distributed nationwide in PA, GA, CA, and WA.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2548-2026·2026-07-08
Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.
Product
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2550-2026·2026-07-08
Hillrom VOLARA System patient circuits recalled for nebulizer leakage risk
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can reduce oxygen levels and prevent proper medication delivery.
Product
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0676-2026·2026-07-08
Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2603-2026·2026-07-08
Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.
Product
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·H-1137-2026·2026-07-08
NARA ORGANICS Whole Milk Organic Infant Formula Recalled for Botulinum Contamination
NARA ORGANICS Whole Milk Organic Infant Formula in 24.7 oz and 14.1 oz sizes is being recalled nationwide because the product may be contaminated with Clostridium botulinum.
Product
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 8600
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2672-2026·2026-07-08
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.
Product
GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2026·2026-07-08
DSAEK Pack-RX surgical kits recalled for bacterial contamination
Windstone Medical Packaging is recalling 1,080 DSAEK Pack-RX surgical convenience kits containing Webcol Large Alcohol Prep Pads contaminated with Paenibacillus phoenicis bacteria discovered during a sterilization audit.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0644-2026·2026-07-08
PurPrep Povidone Iodine and Isopropyl Alcohol Applicators Recall
CareFusion 213, LLC is recalling PurPrep sterile applicators distributed nationwide because unsterilized units intended for further processing were distributed to customers outside the intended channel.
Product
PURPREP — PURPREP (POVIDONE IODINE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2632-2026·2026-07-08
CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide
Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.
Product
CRE Wireguided 6-8mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2640-2026·2026-07-08
Cyberknife Treatment Delivery System Collimator Docking Failure Risk
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0645-2026·2026-07-08
ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2624-2026·2026-07-08
Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
Product
Medtronic Harmony Delivery Catheter System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2026·2026-07-08
Reprocessed Electrophysiology Catheters Recalled for Residual Particles
Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.
Product
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2605-2026·2026-07-08
Omnipod Eros Pod Insulin Delivery Failure Risk
Insulet Corporation is recalling Omnipod (Eros) Pod units due to external soft cannula damage during manufacturing that can cause insulin leakage instead of delivery to the user. High blood glucose levels and serious complications including diabetic ketoacidosis (DKA) or death may result from under-delivery of insulin.
Product
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0653-2026·2026-07-08
IMULDOSA injection recalled due to lack of sterility assurance
Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
IMULDOSA — IMULDOSA (USTEKINUMAB-SRLF)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0647-2026·2026-07-08
ChloraPrep One-Step Antiseptic Applicators Distributed Without Sterilization
CareFusion 213, LLC is recalling 7,650 units of ChloraPrep One-Step antiseptic applicators distributed nationwide because unsterilized product intended for further processing was distributed through incorrect channels.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·26V441000·2026-07-08
BMW Recalls 29,119 Vehicles Due to Starter Relay Fire Risk
BMW is recalling 29,119 vehicles because a corroded starter relay may overheat and short circuit, increasing the risk of a fire.
Product
BMW — BMW 530E XDRIVE IPERFORMANCE, 740LE XDRIVE IPERFORMANCE, 530E IPERFORMANCE, 330E IPERFORMANCE
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0650-2026·2026-07-08
ChloraPrep One-Step Sterile Solution Lacks Assurance of Sterility
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) applicators distributed nationwide. The products were unsterilized and distributed outside the intended channel intended for further processing and sterilization.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0649-2026·2026-07-08
ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·26V438000·2026-07-08
BMW and Toyota vehicles recalled due to engine starter fire risk
BMW of North America, LLC is recalling various BMW and Toyota Supra models because the engine starter may overheat and catch fire.
Product
TOYOTA — TOYOTA, BMW SUPRA, Z4, X4, X3
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·H-1128-2026·2026-07-08
MOGO PURE MORINGA OLEIFERA CAPSULES HERBAL SUPPLEMENT CONTAMINATION RECALL
MOGO PURE MORINGA OLEIFERA CAPSULES herbal supplement is recalled due to potential Salmonella Typhimurium contamination. The affected product was sold nationwide via online retailers.
Product
MOGO PURE MORINGA OLEIFERA CAPSULES, HERBAL SUPPLEMENT, 180 QUICK RELEASE VEGGIE CAPSULE, 100% PURE, 350 MG PER CAPSULE, SUPPLEMENT FACTS MORINGA POWDER 1050 mg, Ingredients: 100% Pure Moringa Leaf Powder (Moringa Oleifera), MANUFACTURED IN USA AND Marketed by: MOGO MIRINGA LLC,
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2644-2026·2026-07-08
Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Category
Medical Device
Distribution
Distributed nationwide

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376–400 of 36488