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

20001–20025 of 40248

HighFDA (Devices)·Z-2154-2019·2019-08-14
SenTec Neonatal Starter Set Recalled for Potential Electrolyte Application Defect
SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.
Product
SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2202-2019·2019-08-14
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.
Product
VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2140-2019·2019-08-14
Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect
Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2200-2019·2019-08-14
Hycor Biomedical Recalls HYTEC 288 System and RF Assay Kits
Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.
Product
HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2221-2019·2019-08-14
ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets
ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.
Product
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2153-2019·2019-08-14
SenTec Standard Starter Set Recalled for Potential Electrolyte Deficiency
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
Product
SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2209-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP0110G. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2019·2019-08-14
Gk Photonics Spectrum Laser Projection Series Recalled for Safety Defect
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation exposure.
Product
Spectrum Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2096-2019·2019-08-14
Gk Photonics Logolas Laser Projectors Recalled for Safety Interlock Defect
Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.
Product
Logolas Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2148-2019·2019-08-14
Olympus MAJ-209 Single Use Suction Valves Recalled for Potential Malfunction
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
Product
Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2151-2019·2019-08-14
Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.
Product
Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2165-2019·2019-08-14
Centurion Neonatal PICC Insertion Tray Recalled for Packaging Compromise
Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.
Product
NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2206-2019·2019-08-14
Integra LifeSciences Recalls Codman ISOCOOL Bipolar Forceps Due to Insulation Defect
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
Product
Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-2138-2019·2019-08-14
MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
Product
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (Vertical) - REF ECP0110GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2180-2019·2019-08-14
Ortho VITROS 5600 Analyzer Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
Product
VITROS 5600 Integrated System, clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2187-2019·2019-08-14
Philips CT System Recall for Incorrect Cardiac Image Labeling
Philips is recalling 116 CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity Core128 Model # 728323, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2143-2019·2019-08-14
Biomet 3i Recalls Certain Bellatek Tin Abutments Due to Manufacturing Defect
Biomet 3i is recalling 2 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Product
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2175-2019·2019-08-14
Ortho VITROS 250 Chemistry System Recalled for Software Calibration Anomaly
Ortho Clinical Diagnostics is recalling two VITROS 250 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Product
VITROS 250 Chemistry System, clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2216-2019·2019-08-14
MedComp Recalls Hemodialysis Catheter Kits Due to Labeling Error
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly describe the included introducer as valved.
Product
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2178-2019·2019-08-14
Ortho VITROS Calibrator Kit 32 Recalled for Software Anomaly
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Product
VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2191-2019·2019-08-14
Philips Brilliance 64 CT System Recalled for Image Labeling Error
Philips is recalling 582 Brilliance 64 CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Brilliance 64 Model # 728231, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2215-2019·2019-08-14
MedComp Recalls Hemodialysis Catheter Kits Due to Introducer Mismatch
Medical Components, Inc. is recalling 6,830 hemodialysis catheter insertion kits because the tray labels incorrectly identify the included introducer as valved.
Product
14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2193-2019·2019-08-14
Philips Ingenuity TF PET/CT Recalled for Cardiac Image Labeling Error
Philips is recalling 12 Ingenuity TF PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Product
Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2223-2019·2019-08-14
Opternative Recalls Visibly Online Refractive Vision Test Software
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
Product
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision…
Category
Medical Device
Distribution
Distributed nationwide

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20001–20025 of 40248