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

2376–2400 of 5111

SevereFDA (Devices)·Z-2288-2020·2020-06-17
Arrow FlexTip Plus Epidural Kit Recalled for Filter Leak
Arrow International is recalling FlexTip Plus Epidural Kits because a rotatable collar on the filter may detach, causing a leak.
Product
Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product Codes (OUS) AT-05501-NRF OT19HBPSS UM-05400-NRF ASK-05500-NRON EJ-05400-NRON OU-05500-NRON TU-05500-NRON The Arrow Epidural
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2342-2020·2020-06-17
RayStation 6 Service Pack 2 Radiation Therapy Software Recalled for Dose Calculation Error
RaySearch Laboratories is recalling RayStation 6 Service Pack 2 software due to a calculation error that could underestimate radiation dose.
Product
RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2279-2020·2020-06-17
Genicon Natura Trocar Recall Due to Potential Tip Detachment
Genicon, Inc. is recalling Natura Model 210-005-052 trocars because the plastic optical tip may detach from the metal shaft.
Product
Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2330-2020·2020-06-17
Medtronic Mazor X Surgical System Positioner Recalled for Detachment Risk
Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.
Product
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-2261-2020·2020-06-10
Spacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure
Spacelabs Healthcare is recalling Xhibit Central software due to reports of audio alarm loss after power failures or cable disconnections, which could delay alarm recognition.
Product
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2257-2020·2020-06-10
Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification
Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.
Product
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2210-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2217-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Failure
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the closure top may back out of the screw post-operatively.
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2174-2020·2020-06-10
FDA Recalls Sterile Surgical Packs Due to Unregistered Facility
American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.
Product
Sterile Custom Packs to be used in surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2207-2020·2020-06-10
Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.
Product
NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-2255-2020·2020-06-10
FDA Recalls Multifire Endo Hernia Staplers Due to Assembly Error
The FDA is recalling 12,610 Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly.
Product
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2229-2020·2020-06-10
FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.
Product
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2254-2020·2020-06-10
Multifire Endo Hernia Stapler Recalled for Manufacturing Assembly Error
Covidien is recalling Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly during use.
Product
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2233-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated f
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2206-2020·2020-06-10
Medtronic Implantable Insulin Pump Recalled for Endotoxin Contamination
Medtronic is recalling 24 implantable insulin pumps due to endotoxin levels exceeding specifications. The devices were distributed only in the Netherlands, France, and Sweden.
Product
Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2219-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2231-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2258-2020·2020-06-10
GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect
GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.
Product
System, Tomography Computed Emmission
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-2205-2020·2020-06-10
Umano Medical Recalls AC Powered Hospital Adjustable Beds
Umano Medical is recalling 3,259 AC powered hospital adjustable beds due to a potential hazard of unsupervised patients falling out of bed.
Product
AC Powered hospital adjustable bed.
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-2211-2020·2020-06-10
Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Product
Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2165-2020·2020-06-10
Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error
Insulet Corporation is recalling 1,773 Omnipod DASH Insulin Management Systems (mmol/L configuration) because the Bolus Calculator may fail to accurately subtract insulin on board after two months of use.
Product
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2058-2020·2020-06-03
Heartware HVAD Pump Outflow Graft Recalled for Potential Tears and Screw Breakage
Heartware, Inc. is recalling HVAD Pump Outflow Grafts because the graft may tear or the strain relief screw may break during pre-implant assembly.
Product
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2056-2020·2020-06-03
Heartware Recalls HVAD Pump Implant Kits Due to Graft Tears and Screw Breakage
Heartware, Inc. is recalling 2,225 HVAD Pump Implant Kits because the outflow graft may tear and the strain relief screw may break during pre-implant assembly.
Product
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2128-2020·2020-06-03
Siemens Cios Spin X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling 20 Cios Spin X-Ray systems because unplugging the monitor cable can create unsafe voltage, posing an electrical shock hazard.
Product
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Category
Medical Device
Distribution
Distributed nationwide

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