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

15426–15450 of 27500

HighFDA (Devices)·Z-2220-2019·2019-08-14
ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets
ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.
Product
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" 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-2093-2019·2019-08-14
Gk Photonics Atom Laser Projection Series Recalled for Safety Compliance
Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.
Product
Atom Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2074-2019·2019-08-14
St Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Product
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2097-2019·2019-08-14
Gk Photonics Recalls Burstberry Laser Projection Series for Safety Defect
Gk Photonics Inc is recalling the Burstberry Laser Projection Series because the provided remote interlock dongle fails to meet FDA safety requirements, posing a risk of high-power laser radiation exposure.
Product
Burstberry Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2201-2019·2019-08-14
Abbott Alinity ci-series System Control Modules Recalled for Software Defect
Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.
Product
The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2166-2019·2019-08-14
Centurion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.
Product
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2213-2019·2019-08-14
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 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2095-2019·2019-08-14
Gk Photonics Maxim Laser Projection Series Recalled for Safety Defect
Gk Photonics is recalling the Maxim Laser Projection Series because the provided remote interlock dongle may not fully comply with FDA safety requirements, potentially exposing users to high-power laser radiation.
Product
Maxim Laser Projection Series
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2167-2019·2019-08-14
Centurion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.
Product
DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2172-2019·2019-08-14
Centurion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise
Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.
Product
LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2222-2019·2019-08-14
MicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall
MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.
Product
SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-2169-2019·2019-08-14
Centurion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk
Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because sterile packaging may be compromised, posing a risk of infection.
Product
DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2019·2019-08-14
Centurion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 220 Circumcision Tray kits (Lot # 2019052190) because the sterile packaging may be compromised, posing a risk of infection during newborn procedures.
Product
CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2214-2019·2019-08-14
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 problems, and failure to obtain tissue samples.
Product
EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2212-2019·2019-08-14
Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues
Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports 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 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2019·2019-08-14
Comet Technologies Recalls YXLON Cheetah Cabinet X-Ray Systems
Comet Technologies is recalling 77 YXLON Cheetah cabinet X-Ray systems because the door interlock fails to meet federal performance standards for power disconnection.
Product
YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2019·2019-08-14
Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect
Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Product
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - 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-2171-2019·2019-08-14
Centurion Universal Block Tray Recalled for Potential Sterile Packaging Compromise
Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.
Product
UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2019·2019-08-14
SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect
SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.
Product
SenTec Membrane Changer Insert [5 pcs - 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 patients the SDMS is indicated for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2203-2019·2019-08-14
Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.
Product
Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2196-2019·2019-08-14
Siemens Lantis 8.3 Commander Recalled for Windows RDP Vulnerability
Siemens is recalling two Lantis 8.3 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Product
Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2164-2019·2019-08-14
Centurion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.
Product
CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2173-2019·2019-08-14
Centurion Medical Recalls Suture Trays Due to Sterile Packaging Concerns
Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.
Product
SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2152-2019·2019-08-14
SenTec Membrane Changer Recall Due to Electrolyte Application Defect
SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.
Product
SenTec Membrane Changer (reloadable) [9 pcs] - 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 patients the SDMS is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2161-2019·2019-08-14
Centurion Recalls Sterile Graves Vaginal Speculums Due to Packaging Compromise
Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.
Product
STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facilitate examination. It is used by medical professionals in a clinical setting.
Category
Medical Device
Distribution
Distributed nationwide

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