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

12901–12925 of 13837

ModerateFDA (Devices)·Z-0014-2022·2021-10-13
Scan Abutment NP Dental Implant Components Recalled for Dimensional Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment NP dental implant components due to manufacturing tolerance deviations that may affect implant restoration fit and timing.
Product
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0013-2022·2021-10-13
Paltop Scan Abutment SP Recalled for Dimensional Tolerance Deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment SP devices due to manufacturing tolerance deviations that may delay dental restoration. Affected devices showed orientation misalignment and size engraving errors.
Product
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2582-2021·2021-10-06
Ultrasound Gel Products Recalled for Possible Bacterial Contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.
Product
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco Ultrasound Gel, 5 liters; NC70479-5/North Coast Ultrasound Gel, 5 liters; NC70479-5C/Norco Ultrasound Gel, 5 liters (4); NC70479-5C/North Coas
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2592-2021·2021-10-06
Atrium Pneumostat Chest Drain Valve Recalled Following Fatal Preterm Infant Case
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Category
Medical Device
Distribution
Distributed nationwide
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 (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-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-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 (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
HighFDA (Devices)·Z-2581-2021·2021-10-06
Dose Calibrator Software Bug May Cause Incorrect Isotope Measurements
AtomLab 500Plus Dose Calibrator software versions 2.0.00–2.0.08 contain a bug that fails to remove dial settings when deleting custom isotopes, potentially causing incorrect dose calibrations and misadministration.
Product
AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2612-2021·2021-10-06
Corin Unity Knee Patella components recalled due to packaging damage
Corin is recalling Corin Unity Knee Patella components due to potential packaging damage that could compromise sterility and device integrity. Affected units were distributed in nine US states in July 2021.
Product
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, 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
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-2590-2021·2021-10-06
Mobile X-Ray System Recalled for Unexpected Column Motion During Parking
GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.
Product
AMX Navigate Mobile X-Ray System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2557-2021·2021-10-06
B. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays
B. Braun Medical is recalling 768 units of Outlook Pump Set 3 infusion sets due to potential leakage that could delay or prevent complete medication delivery and increase risk of bloodstream infection.
Product
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490564
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2591-2021·2021-10-06
MOSAIQ Oncology Information System software defect reverts approved drug strength
The MOSAIQ Oncology Information System has a software defect where approved changes to drug strength revert to the original value when saved, potentially resulting in incorrect medication dosages.
Product
MOSAIQ Oncology Information System
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-2553-2021·2021-10-06
B. Braun Outlook Pump Set Recall: Risk of Leakage and Medication Under-Delivery
B. Braun is recalling 1,752 Y-Type Blood Outlook Pump Set units due to leakage in the cassette portion. The defect may cause delays in medication administration, incomplete dosing, or bloodstream infections.
Product
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2609-2021·2021-10-06
Corin MetaFix Hip Stem Recalled Due to Potential Packaging Damage
Corin Ltd is recalling Corin MetaFix Hip Stem, Size 1 devices due to potential physical and water damage to packaging that could compromise device sterility and cause contamination.
Product
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2021·2021-10-06
Patient Lift Device Stretch Leveller May Lose Horizontal Position Control
Hill-Rom LikoStretch 1900 patient lift devices may lose their ability to maintain horizontal position during lifting, risking patient falls. Affected devices can cause patients to slide out of the lift sheet.
Product
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2603-2021·2021-10-06
Corin TriFit TS Orthopedic Implant Recall Due to Packaging Damage and Sterility Loss
Corin Ltd is recalling Corin TriFit TS orthopedic implants due to packaging damage that may cause sterility loss and device contamination. The affected devices were shipped in July 2021 to multiple US states.
Product
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2556-2021·2021-10-06
Outlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
B. Braun is recalling 7,248 units of Outlook Pump Set that may leak or fail to deliver medications properly, potentially causing bloodstream infections.
Product
OUTLOOK PUMP SET, 3 CARESITE LADS, 115 IN-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 490361
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2562-2021·2021-10-06
LYMOL Medical Elite X Class Rigid Bronchoscope System — Updated reprocessing instructions not distributed
Lymol Medical Corporation recalled the LYMOL Medical Elite X Class Rigid Bronchoscope System because updated reprocessing instructions issued November 15, 2020, were not sent to all consignees of the devices.
Product
LYMOL Medical Elite X Class Rigid Bronchoscope System, Part No. BD2410, BB2701, BB2702, BB2401, BB2402, BA2700, BT2000, BT2101, BT2103, BT2105, BT2106, BT2210, BT2201, BT2203, BT2205, BR2200, BP2200, BI2200, BR2000, BP2000, BI2999, BR2103, BP2103, BI2103, BR2101, BP2101, BI2101,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2021·2021-10-06
Corin Trinity-i Acetabular Components Recalled Due to Packaging Damage
Corin Ltd is recalling Corin Trinity-i acetabular components (50mm diameter, Taper Size 3) distributed nationwide due to potential physical and water damage to the packaging system, which may compromise device sterility or cause contamination.
Product
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2554-2021·2021-10-06
Outlook Pump IV Set Recalled Due to Cassette Leakage and Infection Risk
B. Braun Medical is recalling Outlook Pump IV Sets due to cassette leakage that may delay medication delivery and cause incomplete dosing or bloodstream infections.
Product
OUTLOOK PUMP IV SET, 134 IN.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477009
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2589-2021·2021-10-06
Atrium ADVANTA VXT Vascular Graft may lack required radial support ring
Atrium Medical Corporation is recalling 28 units of the Atrium ADVANTA VXT Vascular Graft because some packages may contain mismatched units lacking the radial support ring specified in labeling.
Product
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Category
Medical Device
Distribution
Distributed nationwide

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12901–12925 of 13837