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

24301–24325 of 26082

SevereFDA (Devices)·Z-2577-2021·2021-10-06
Reperfusion Catheter Recalled Due to Risk of Distal End Fracture
Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.
Product
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0899-2021·2021-10-06
Testosterone Cypionate/Propionate Injection Recalled for Sterility Assurance
New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.
Product
Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0856-2021·2021-10-06
Morphine Sulfate Injection Recalled Due to Defective Vials
Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0008-2022·2021-10-06
Ruzurgi (amifampridine) Tablets Recalled for Microbial Contamination
Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.
Product
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-1017-2021·2021-10-06
Velvet Ice Cream Raspberry Fudge Cordial Recalled for Undeclared Allergen
Velvet Ice Cream Company is voluntarily recalling Velvet Ice Cream Raspberry Fudge Cordial because it contains an undeclared allergen that is not listed on the label.
Product
Velvet Ice Cream Raspberry Fudge Cordial 1.75 quarts (56oz) 6 quarts per case
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1027-2021·2021-10-06
Vanilla Flavor Imitation recalled for undeclared allergens and food dyes
Medina Baking and Powder Products, Inc. is recalling Vanilla Flavor Imitation (White) in 128 fl. oz. gallons due to undeclared egg, Yellow #5, Red #40, and Blue #1. Consumers with allergies or sensitivities to these ingredients face potential health risks.
Product
Vanilla Flavor Imitation (White), Net Contents 128 FL. OZS. (1 Gallon)
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2583-2021·2021-10-06
Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination Risk
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA issued a Class I recall on August 18, 2021.
Product
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2518-2021·2021-10-06
FDA Recalls Ultrasound Gels for Bacterial Contamination Risk
Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.
Product
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2499-2021·2021-10-06
DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching
DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.
Product
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2587-2021·2021-10-06
GENOSYL DS vasodilator console recalled for reversed gas lines defect
Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.
Product
GENOSYL DS (Delivery System) console, for use as a vasodilator.
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0897-2021·2021-10-06
ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance
IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.
Product
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
Category
Drug
Distribution
3 states
HighFDA (Devices)·Z-2542-2021·2021-10-06
Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use
Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.
Product
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2548-2021·2021-10-06
Infusion Pump Sets Recalled for Leakage and Medication Under-Delivery Risk
B. Braun Medical is recalling infusion pump sets that may leak, potentially causing delayed medication delivery, incomplete dosing, and bloodstream infections.
Product
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2584-2021·2021-10-06
Operating Room Table Rotational Lock May Fail Due to Hardware Defect
The rotational locking mechanism on certain ORT200/300 operating room tables may fail to lock or unlock due to a mechanical hardware defect. Affected tables have been distributed worldwide.
Product
Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2551-2021·2021-10-06
Outlook V1500HP Pump Set Recalled for Cassette Leakage
The Outlook V1500HP Pump Set is recalled due to cassette leakage that could delay medication delivery, reduce dosing accuracy, and cause bloodstream infections. The recall involves 12,000 units distributed in the US and Canada.
Product
V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2550-2021·2021-10-06
Outlook pump extension sets recalled due to leakage and dosing errors
Outlook infusion pump extension sets may leak, potentially delaying medication delivery and causing bloodstream infections.
Product
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 470024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2610-2021·2021-10-06
Corin Unity Knee Augments Recalled Due to Packaging Damage and Sterility Loss
Corin Ltd is recalling Corin Unity knee implant augments because packaging damage could compromise device sterility and allow contamination. Affected units were distributed in 9 states during July 2021.
Product
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2021·2021-10-06
Corin Trinity Bone Screws Recalled for Potential Packaging Damage and Sterility Loss
Corin Ltd is recalling specific lots of Trinity Acetabular System bone screws due to potential packaging damage that could result in loss of sterility or device contamination.
Product
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V781000·2021-10-06
2022 Volvo VNL trucks recalled for unexpected transmission neutral shift
Volvo Trucks is recalling 2022 VNL trucks due to electronic control software that may cause the transmission to shift into neutral unexpectedly, increasing crash risk.
Product
VOLVO — 2022 VOLVO VNL
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1025-2021·2021-10-06
De Wafelbakkers Buttermilk Pancakes Recalled for Listeria Contamination
De Wafelbakkers 18 ct Buttermilk Pancakes are being recalled nationwide because they may contain Listeria monocytogenes. Consumers should not eat the product.
Product
De Wafelbakkers 18 ct Buttermilk Pancakes NET WT 1 lb. 8.7 oz. (703g) KEEP FROZEN packaged in clear flexible plastic UPC 679844104573
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2021·2021-10-06
Corin BIOLOX Delta Mod Head hip implant components recall due to packaging damage
Corin Ltd is recalling Corin BIOLOX Delta Mod Head hip implant components due to packaging system damage that could result in loss of sterility or device contamination. Affected units were distributed nationwide to nine states.
Product
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2021·2021-10-06
Corin Trinity Liner hip implant components recalled due to packaging damage
Corin Ltd is recalling specific Trinity Liner ECIMA hip implant components because packaging damage could compromise device sterility or cause contamination. Five units were distributed nationwide between July 22-26, 2021.
Product
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2563-2021·2021-10-06
Radiation therapy planning software can save contours to wrong image set
Elekta Monaco radiation therapy planning software has a defect allowing contour edits to be saved to the wrong image set without freezing the radiation dose for affected treatment plans.
Product
Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2558-2021·2021-10-06
Outlook Pump Add-On Set Recalled for Potential Leakage and Under-Delivery
B. Braun Medical is recalling the Outlook Pump Add-On Set due to potential leakage that may delay medication delivery and cause incomplete dosing. The affected units could increase the risk of bloodstream infections.
Product
Outlook Pump Add-On Set-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: V7400
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2021·2021-10-06
Anesthesia Flow Sensors Recalled for Tube Damage and Potential Gas Leaks
GE Healthcare is recalling approximately 310,000 replacement flow sensors for anesthesia machines manufactured before June 2021. The sensors may have damaged tubes that leak, causing incorrect anesthesia delivery to patients.
Product
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOC
Category
Medical Device
Distribution
Distributed nationwide

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24301–24325 of 26082