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

12851–12875 of 13802

ModerateFDA (Devices)·Z-0022-2022·2021-10-13
OPTETRAK Comprehensive Knee System Custom Inserts Recalled for Packaging Defect
Exactech, Inc. is recalling 41 custom OPTETRAK knee implant inserts due to packaging defects. The inserts were packaged in vacuum bags lacking adequate oxygen barrier protection.
Product
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06-XX, 900-08-XX); b. CUSTOM OPTETRAK CC TIBIAL INSERT (Product Line: 900-23-XX, 900-30-XX); c. CUSTOM OPTETRAK CC INSERT (Product Line:
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0019-2022·2021-10-13
OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier
Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.
Product
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0050-2022·2021-10-13
Zoll ICY Heat Exchange Catheter Kit Labeling Update Due to Potential Leaks
ZOLL Circulation is updating labeling for its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 1,256 units distributed worldwide.
Product
Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0037-2022·2021-10-13
Medical cooler-heater device recalled for inadequate maintenance and inspection guidance
CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.
Product
CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
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
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-0038-2022·2021-10-13
Cardiac Cooler-Heater Device Lacks Maintenance and Inspection Guidance
CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.
Product
CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134
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-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
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-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-0020-2022·2021-10-13
Orthopedic Knee Implants Lack Protective Oxygen Barrier in Packaging
Exactech OPTETRAK Comprehensive Knee System inserts were packaged in vacuum bags lacking an additional oxygen barrier layer, which could allow material degradation. The recall affects 2,774 devices distributed worldwide.
Product
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0039-2022·2021-10-13
Zoll ICY Intravascular Catheter Kit: Labeling Update on Potential Leaks
ZOLL is updating labeling for ICY Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or tubing. Healthcare providers should review updated guidance from the manufacturer.
Product
Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0063-2022·2021-10-13
Zoll Cool Line Catheter Kits Recalled Due to Potential Tubing Leaks
ZOLL Circulation recalls Cool Line (Heparin) IVTM catheter kits due to potential leaks in catheter or start-up kit tubing. The recall affects 144 bundles distributed worldwide.
Product
Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Category
Medical Device
Distribution
Distributed nationwide
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-0018-2022·2021-10-13
Dental implant scan abutment recalled for dimensional tolerance and marking defects
Paltop Scan Abutment WP dental implant scanning devices are recalled due to manufacturing defects. Affected units show dimensional tolerance deviations and size marking incongruences that may delay restoration procedures.
Product
Scan Abutment WP, Cat. No. 30-70106 - 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
ModerateFDA (Devices)·Z-0017-2022·2021-10-13
Scan Abutment PCA dental implant component recalled for tolerance deviations
Paltop Advanced Dental Solutions is recalling Scan Abutment PCA devices due to manufacturing tolerance deviations that may delay implant restoration. Some devices show up to 2-degree orientation variance and sizing discrepancies.
Product
Scan Abutment PCA, Cat. No. 30-70105 - 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 surgic
Category
Medical Device
Distribution
Distributed nationwide
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
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-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

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12851–12875 of 13802