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 the agency’s own highest classification or reported deaths or serious injuries, 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

14976–15000 of 39988

SevereFDA (Devices)·Z-1205-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 12mm Material Number: 66-112 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1228-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1244-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1234-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 84mm Material Number: 66-484 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1227-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 63mm Material Number: 66-363 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1239-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1237-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring surgical revision.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 105mm Material Number: 66-5105 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1213-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1225-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1235-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1207-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1240-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 85mm Material Number: 66-585 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1176-2021·2021-03-17
Canon Medical System INFX-8000F X-ray Systems Recalled for Field Shift
Canon Medical System is recalling 272 INFX-8000F systems because the x-ray field may shift at certain angles.
Product
System INFX-8000F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2021·2021-03-17
Draeger VentStar Watertrap Breathing Circuits Recalled for Detachment Risk
Draeger Medical is recalling 150 units of VentStar Watertrap (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.
Product
VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1175-2021·2021-03-17
Canon Medical System INFX-8000C C-Arm Recall for X-Ray Field Shift
Canon Medical System is recalling 272 INFX-8000C C-arm systems nationwide because the x-ray irradiation field may shift relative to the displayed image at certain angles.
Product
System INFX-8000C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2021·2021-03-17
Dräger ID Circuit Basic Breathing Circuits Recalled for Detachment Risk
Dräger Medical is recalling ID Circuit Basic (N) 180 breathing circuits because the Y-piece may detach, causing a leak that hinders patient ventilation.
Product
ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2021·2021-03-17
Sunstar G.U.M. Hydral Dry Mouth Spray Recalled for Bacterial Contamination
Sunstar Americas is recalling 56,960 bottles of G.U.M. Hydral Dry Mouth Relief Oral Spray due to potential Burkholderia cepacia contamination.
Product
SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1203-2021·2021-03-17
Insulet Recalls Omnipod DASH User Guides Due to Decimal Error
Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.
Product
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1186-2021·2021-03-17
Stryker Recalls Triathlon Knee Baseplates Due to Manufacturing Defect
Stryker is recalling 11 Triathlon Tritanium Tibial Baseplates because a manufacturing defect may prevent the knee insert from locking securely.
Product
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1181-2021·2021-03-17
Getinge Flow i Anesthesia Systems Recalled for Absorber Docking Failures
Getinge Group Logistics America is recalling 144 Flow i Anesthesia Systems due to complaints of incorrect FiCO2 readings and System Check Out failures when docking the absorber.
Product
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with limited ability to breathe.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1174-2021·2021-03-17
Canon Medical System INFX-8000V X-ray System Recalled for Field Shift
Canon Medical System is recalling 272 INFX-8000V systems because the x-ray field may shift relative to the displayed image at certain angles.
Product
System INFX-8000V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2021·2021-03-17
Medtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
Medtronic Vascular is recalling 6F Launcher Guide Catheters because an unsealed pouch may compromise sterility.
Product
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1202-2021·2021-03-17
Thermo Fisher Recalls Cascadion Clinical Analyzer Due to Software Defect
Thermo Fisher Scientific is recalling 19 Cascadion Clinical Analyzers because a software defect may cause false Vitamin D deficiency results.
Product
Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1178-2021·2021-03-17
Dräger VentStar Basic Breathing Circuits Recalled for Detachment Risk
Draeger Medical is recalling 1,525 VentStar Basic breathing circuits because a Y-piece may detach, causing a leak that hinders patient ventilation.
Product
VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1187-2021·2021-03-17
Tosoh Thyroglobulin Antibody Calibrator Recalled for Calibration Failures
Tosoh Bioscience Inc is recalling specific lots of Thyroglobulin Antibody Calibrators because some combinations with AIA PACKS resulted in unacceptable calibration values.
Product
Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the…
Category
Medical Device
Distribution
Distributed nationwide

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14976–15000 of 39988