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

12876–12900 of 13816

ModerateFDA (Devices)·Z-0046-2022·2021-10-13
ZOLL ICY Intravascular Catheter Kit: Labeling Update for Potential Leaks
ZOLL Circulation recalls 333 units of its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update addresses the leak risk affecting medical facilities worldwide.
Product
ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0033-2022·2021-10-13
Medical Device Calibrator Kit Recall for Incorrect Labeling
FDA recalls Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit due to incorrectly labeled calibrator vials in Lot 00681Y600. The labeling error prevents the instrument from completing calibration successfully.
Product
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0032-2022·2021-10-13
Beckman Coulter Troponin I Reagent Packs Recalled Due to Sample Contamination
Beckman Coulter is recalling 293,640 Access hsTnI High Sensitivity Troponin I reagent packs due to sample carryover contamination occurring with very high concentration samples, potentially affecting test accuracy.
Product
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Category
Medical Device
Distribution
44 states
ModerateFDA (Devices)·Z-0042-2022·2021-10-13
ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks
ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.
Product
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0043-2022·2021-10-13
ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks
ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.
Product
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Category
Medical Device
Distribution
Distributed nationwide
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-0016-2022·2021-10-13
Dental implant abutments recalled for orientation and sizing tolerance issues
Paltop Advanced Dental Solutions is recalling Scan Abutment SU devices (Catalog No. 30-70104) manufactured before July 21, 2021, due to manufacturing tolerance deviations that may delay dental restoration.
Product
Scan Abutment SU, Cat. No. 30-70104 - 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 surgica
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
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
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-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-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-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-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-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-2546-2021·2021-10-06
Outlook Pump IV Sets Recalled for Leakage and Infection Risk
B. Braun Medical, Inc. is recalling approximately 44,866 Outlook Pump IV sets due to leakage of the pump set that could delay medication administration and increase the risk of bloodstream infections. The defect may result in under-delivery or incomplete medication dosing.
Product
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2576-2021·2021-10-06
Vysis CLL FISH Probe Kit may fail to detect genetic deletion
Abbott is recalling Vysis CLL FISH Probe Kits that may not detect 13q deletions in patient samples. This could lead to missed diagnosis of a genetic abnormality used in cancer treatment planning.
Product
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes
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-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-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-2616-2021·2021-10-06
Cardiosave Rescue IABP may unexpectedly shut down during operation
Datascope Corp. is recalling the Cardiosave Rescue IABP (models 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85) because the device may unexpectedly shut down when run on AC power with a single battery installed and that battery is removed during charging.
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2021·2021-10-06
Stretch Leveller Model 3156200 May Lose Horizontal Position Control
Hill-Rom's Stretch Leveller Model 3156200 may lose the ability to maintain patients in a horizontal position during lifting, potentially causing patients to slide backward or fall from the lift sheet.
Product
Stretch Leveller Model Number: 3156200 - 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-2544-2021·2021-10-06
B. Braun Infusion Pump Sets Recalled for Leakage and Infection Risk
B. Braun Medical's infusion pump sets may leak, potentially delaying medication delivery and causing incomplete dosing. The defect poses a risk of bloodstream infections.
Product
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212
Category
Medical Device
Distribution
Distributed nationwide

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12876–12900 of 13816