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

12876–12900 of 40151

HighFDA (Devices)·Z-0733-2022·2022-03-16
ExacTrac Dynamic Software Yaw Angle Error May Affect Radiotherapy Positioning
ExacTrac Dynamic radiotherapy positioning software (versions 1.0.0–1.0.3) may calculate incorrect yaw angle for patient positioning with Varian linear accelerators, potentially affecting cone-beam CT imaging setup accuracy during radiotherapy.
Product
ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning and Moni. 1.0.1 INST; 20910-01B, ETD Positioning and Moni. 1.0.2 INST; and 20910-01C ETD Positioning and Moni. 1.0.3 INST.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0747-2022·2022-03-16
Proton Therapy Systems May Fail to Verify Beam Range After Pause
Proton therapy systems from Ion Beam Applications may not verify that beam range settings remain unchanged after treatment pause, risking incorrect treatment delivery if the range was manually modified.
Product
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0741-2022·2022-03-16
FISH Diagnostic Probe Kit Color Labeling Error Affects Test Results
Cytocell Ltd. is recalling a Del(5q) Deletion FISH Probe Kit due to incorrect color labeling on probe components. The mislabeling may cause misinterpretation of test results for patients with AML or MDS.
Product
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0727-2022·2022-03-16
B. Braun dispensing pins recalled for air filter leakage risk
B. Braun Medical is recalling dispensing pins with an elevated leakage risk in the air inlet filter. The leakage may reduce medication doses, delay treatment, or contaminate the fluid path, potentially causing bloodstream infection.
Product
Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2022·2022-03-16
Medtronic endotracheal tubes recalled due to manufacturing nonconformity
Medtronic Xomed is recalling over 301,000 NIM TRIVANTAGE EMG Endotracheal Tubes due to a manufacturing nonconformity. These devices were distributed worldwide.
Product
NIM TRIVANTAGE EMG Endotracheal Tube
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2022·2022-03-16
Philips X-ray System Cooling Leak Poses Fire Risk
Philips Allura CV20 X-ray systems with certain Laird chillers may leak cooling liquid onto electrical components, potentially causing fire or smoke. Affected systems should not be operated until the issue is addressed.
Product
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: 722031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0732-2022·2022-03-16
Radiation therapy planning software displays wrong images during animation playback
RayStation/RayPlan versions 6.0.0.24 through 9.2.0.483 incorrectly display selected images as both primary and secondary when animation playback is running, affecting treatment planning visualization.
Product
RayStation/RayPlan- designed for treatment planning and analysis of radiation therapy. Software Version: 6.0.0.24 , 6.1.0.26 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 .…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0724-2022·2022-03-16
Philips Allura Xper X-ray systems cooling system leak poses fire risk
Philips Allura Xper interventional X-ray systems may experience cooling liquid leaks that could drip on electrical components, creating risk of fire, smoke, or burning odors. No injuries have been reported.
Product
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an extended drip tray: Model Number: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0738-2022·2022-03-16
FDA Recalls Diagnostic Test Strips for False Positive Results
NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.
Product
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2022·2022-03-16
Diagnostic Testing Plates Recalled for Inaccurate Antibiotic Susceptibility Results
Remel Inc is recalling 1210 Thermo Sensititre Gram Negative Testing Plates due to inaccurate susceptibility results that could affect antibiotic resistance testing.
Product
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0739-2022·2022-03-16
Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect
Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.
Product
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0729-2022·2022-03-16
Vascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
A vascular graft has been recalled due to labeling mismatch: the outer package label differs from the inner sterile packaging in graft type and dimensions. Implanting the wrong size could disrupt blood vessel connections and create a pseudo-aneurysm.
Product
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2022·2022-03-16
Surgical hammertoe instruments recalled for potential locking mechanism deformation
The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision surgery.
Product
Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0735-2022·2022-03-16
Laboratory diagnostic tips recalled for potential dispensing errors
Ortho-Clinical Diagnostics is recalling VITROS Chemistry VersaTips due to shape deformity that may reduce sample volume by 16%. Undetected errors could result in inaccurate test results for bloodborne infectious disease assays.
Product
VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0728-2022·2022-03-16
Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
Product
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0736-2022·2022-03-16
CoolSeal Generator manufacturing defect may cause unintended energy delivery to patients
CoolSeal Generator units (REF: CSL-200-50) may have a manufacturing defect preventing them from meeting electrical safety standards, potentially resulting in unintended energy delivery to patients.
Product
CoolSeal Generator, REF: CSL-200-50
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0746-2022·2022-03-16
PCA 4000 Dental Curing Units May Not Fully Cure Resins
Envisiontec is recalling 172 PCA 4000 curing units that may not properly cure dental resins to specification (SKU ACC-06-1000).
Product
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0731-2022·2022-03-16
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Incorrect Expiration Dates
Celltrion USA Inc. is recalling 1.2 million DiaTrust COVID-19 rapid test kits due to incorrect expiration dates on packaging. The kits were distributed to 11 states.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0726-2022·2022-03-16
HeartWare HVAD System: Updated Cleaning Instructions for Power Connectors
Updated cleaning instructions are being provided for the HeartWare HVAD System's power connectors. Improper cleaning can remove protective lubricant required for proper power switching.
Product
HeartWare Ventricular Assist Device (HVAD) System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0723-2022·2022-03-16
CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation
Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.
Product
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0744-2022·2022-03-16
PuraSinus Nasal Hemostat Recalled Due to Unvalidated Shipping Boxes
3-D Matrix, Inc. is recalling PuraSinus Absorbable Nasal Hemostat units because the shipping boxes used for transport were not validated.
Product
PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2022·2022-03-16
HeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads
Physio-Control shipped HeartSine Samaritan PAD (SAM 350P) semi-automatic defibrillators without required battery and electrode packs. Affected units are non-functional without these essential components.
Product
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0680-2022·2022-03-09
Celltrion DiaTrust COVID-19 Rapid Test Kits Recalled for Unauthorized Clinical Use
Celltrion USA recalled COVID-19 rapid test kits (DiaTrust) in a Class I action. The kits are labeled for research use only, but the firm assured distributors they could be used for clinical diagnosis, which is not authorized.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0663-2022·2022-03-09
Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled
Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.
Product
Philips Respironics V60 Plus Ventilator Part Number 1138747
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-0659-2022·2022-03-09
COVID-19 Rapid Test Kits Recalled for Risk of False Positive Results
Celltrion DiaTrust COVID-19 Ag Rapid Test kits from lot COVGCCM0008 are being recalled due to reports of false positive results. The affected 243 kits were distributed to six states before the recall.
Product
Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Category
Medical Device
Distribution
6 states

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12876–12900 of 40151