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 27471

HighFDA (Devices)·Z-2276-2019·2019-08-21
NeuroLogica WS80A Diagnostic Ultrasound System Recalled for Probe Overheating Risk
NeuroLogica is recalling WS80A Diagnostic Ultrasound Systems because probes may overheat when users decrease the Doppler Sample Volume size in Doppler Only mode.
Product
WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2073-2019·2019-08-14
St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
Product
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2072-2019·2019-08-14
St Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures
St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Product
ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2204-2019·2019-08-14
Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes
Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.
Product
LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2168-2019·2019-08-14
Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns
Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.
Product
HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2075-2019·2019-08-14
St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Product
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2019·2019-08-14
Intellijoint G2 Workstation Recalled Due to MacBook Pro Fire Risk
Intellijoint Surgical is recalling 23 G2 Workstations because the Apple MacBook Pro components may overheat and pose a fire safety risk.
Product
Workstation, G2, Configured (P/N 000-0241)
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-2219-2019·2019-08-14
Ideal Implant Recalls Structured Saline Breast Implants Due to Deflation
Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.
Product
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2070-2019·2019-08-14
St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
Product
ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2092-2019·2019-08-14
Gk Photonics ClubMax Laser Projectors Recalled for Safety Interlock Defect
Gk Photonics is recalling ClubMax Laser Projection Series units because the remote interlock dongle may fail to prevent high-power laser exposure.
Product
ClubMax Laser Projection Series
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2071-2019·2019-08-14
St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
Product
ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2019·2019-08-14
SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure
SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.
Product
SenTec Membrane Changer Set (1 charger plus 1 insert) - 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2106-2019·2019-08-14
Comet Technologies Recalls YXLON Cougar Cabinet X-Ray Systems
Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.
Product
YXLON Cougar 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-2137-2019·2019-08-14
MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures
MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.
Product
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant…
Category
Medical Device
Distribution
Distributed nationwide
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

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15426–15450 of 27471