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

11176–11200 of 13717

HighFDA (Devices)·Z-1649-2022·2022-09-07
Metalogix Self-Drill Half-Pin Surgical Component Recalled for Tip Breakage
New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.
Product
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metal
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1650-2022·2022-09-07
FGFR cancer diagnostic kit recalled due to increased false positive results
Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.
Product
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1673-2022·2022-09-07
Eye imaging device software defect affects surgical planning calculations
Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.
Product
Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-1643-2022·2022-09-07
Cell culture medium recalled for improper storage temperature conditions
Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.
Product
AIM-V Medium REF AV.200/500
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1668-2022·2022-09-07
DeRoyal Sterile Custom Kits Recalled for Defective Connectors
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.
Product
DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2022·2022-09-07
X-ray imaging system hardware defect may prevent operation
Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.
Product
Artis pheno- Model No. 10849000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1640-2022·2022-09-07
bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies
bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.
Product
VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-1522-2022·2022-08-31
INTERA 3000 implantable pump recalled for higher-than-expected flow rate
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Product
INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1561-2022·2022-08-31
Diaphragm pacing system external pulse generator recalled for circuit board defect
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
Product
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-1560-2022·2022-08-31
Getinge Servo ventilator systems recalled for loss of ventilation
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
Product
Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1525-2022·2022-08-31
Intensive care ventilator status board may loosen, causing water damage and malfunction
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Product
HAMILTON-C6 Intensive Care Ventilator, REF: 160021
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1629-2022·2022-08-31
Beckman Coulter Laboratory Reagents Recalled for Temperature-Related Effectiveness Loss
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
Product
BECKMAN COULTER, INC. a. COULTER DxH Diff Pack REAGENT, DIFF PK FP DXHCOULTR, Catalog #628020. b. COULTER DxH Cleaner REAGENT, CLEANER FP DXH 10LCOULTR Catalog #628023. c. DxH 500 Series Lyse LYSE, VERSA SOL DXH 500 SERIES(0.5L/KT) Catalog # B36846. d. DxH 500 Serie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1571-2022·2022-08-31
Vanta Clinician Programmer Application error prevents programming of implanted neurostimulators
The Vanta Clinician Programmer Application v2.0.2455 may display Error Code 1502, preventing users from programming Vanta implantable neurostimulators. The issue affects 2,920 downloaded software applications distributed worldwide.
Product
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2022·2022-08-31
Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure
Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1584-2022·2022-08-31
Surgical Hemostatic Matrix Recalled Due to Temperature Exposure During Storage
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
Product
Ethicon SURGIFLO Hemostatic Matrix Kit with Thrombin (6/CS) Ref: 2994 Mfg: FERROSAN MEDICAL DEVICES A/S Indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1578-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1602-2022·2022-08-31
Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness
Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.
Product
NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2022·2022-08-31
MedSource IV Start Kit Recalled for Temperature-Related Effectiveness Loss
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
Product
MedSource IV Start kit, 8inch Extension Set IV START KIT, W/SITE LOC/8" EX100/CS Model Number: MS-80047
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1566-2022·2022-08-31
GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport
GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.
Product
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1564-2022·2022-08-31
NUCLISENS easyMAG Magnetic Silica Reagent Kit Contamination Recall
bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.
Product
NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-1582-2022·2022-08-31
Boston Scientific Guide Catheter Distributed With Wrong Tip Curve
Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.
Product
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1595-2022·2022-08-31
Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure
Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.
Product
Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1628-2022·2022-08-31
Medical Lubricating Jelly Recalled Due to Temperature Excursions During Storage
Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.
Product
FISHER SCIENTIFIC Aseptic Control¿ LUBRICATING JELLY PAP TEST 4OZ(12/PK) Catalog #22998006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1577-2022·2022-08-31
Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns
Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 units distributed worldwide.
Product
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1585-2022·2022-08-31
Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss
ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.
Product
HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
Category
Medical Device
Distribution
Distributed nationwide

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11176–11200 of 13717