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

21851–21875 of 40299

ModerateFDA (Devices)·Z-0376-2019·2018-11-14
Coltene Whaledent Recalls ParaPost Plus Titanium Dental Posts
Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy dental posts because they contain stainless steel posts that are a size 4.
Product
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0374-2019·2018-11-14
GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure
GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.
Product
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-0381-2019·2018-11-14
Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation
Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.
Product
Liquid Cardiac Control, CQ5052
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0404-2019·2018-11-14
Medtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.
Product
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0377-2019·2018-11-14
AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling Endoform Dermal Template 2x2 units due to a potential for pouch seal failure.
Product
Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0405-2019·2018-11-14
Integrity Implants Recalls FlareHawk Interbody Fusion System Instructions for Use
Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.
Product
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0410-2019·2018-11-14
R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error
R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.
Product
R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0389-2019·2018-11-14
Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels
Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.
Product
Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0297-2019·2018-11-07
Siemens Multix Fusion Radiographic Systems Recalled for Lifting Column Cable Defect
Siemens is recalling 35 Multix Fusion radiographic systems because steel cables in the lifting column may rupture without triggering the safety lock, causing the arm to drop unexpectedly.
Product
Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0299-2019·2018-11-07
Siemens Ysio Radiographic Systems Recalled for Potential Tube Arm Drop
Siemens is recalling 142 Ysio radiographic systems because steel cables may rupture, causing the tube arm to drop unexpectedly during patient positioning.
Product
Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0281-2019·2018-11-07
Leica BOND Slide Labeler Printers Recalled for Fire Hazard
Leica Microsystems is recalling BOND Slide Labeler Zebra Printers because the power supply unit may overheat or cause a fire due to an improperly-mixed phosphorus compound.
Product
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0287-2019·2018-11-07
Zimmer Biomet Recalls SpF PLUS-Mini Spinal Fusion Stimulators for Cleanliness Issues
Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.
Product
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0291-2019·2018-11-07
Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk
Stryker GmbH is recalling 867 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the medical device.
Product
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0290-2019·2018-11-07
Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk
Stryker GmbH is recalling 1,355 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising frame stability.
Product
Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0300-2019·2018-11-07
Siemens Ysio MAX Radiographic Systems Recalled for Cable Failure Risk
Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.
Product
Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0099-2019·2018-11-07
Cardiosave Hybrid IABP Recalled for Potential Therapy Interruption at High Altitudes
Maquet Datascope is recalling Cardiosave Hybrid IABP devices due to a potential inability to start therapy for users at altitudes above 3,200 feet.
Product
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0298-2019·2018-11-07
Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk
Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.
Product
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0100-2019·2018-11-07
Maquet Cardiosave Rescue IABP Recalled for High Altitude Therapy Interruption
Maquet Datascope is recalling Cardiosave Rescue IABP devices due to a potential inability to start therapy at altitudes above 3,200 feet.
Product
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0289-2019·2018-11-07
Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk
Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.
Product
Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0288-2019·2018-11-07
Stryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect
Stryker GmbH is recalling 578 Hoffmann LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.
Product
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0286-2019·2018-11-07
Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues
Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.
Product
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0367-2019·2018-11-07
Baxter Recalls EXACTAMIX Empty EVA Bags Due to Potential Leaking
Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.
Product
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0301-2019·2018-11-07
Roche Diagnostics Recalls URISYS 1100 Urine Analyzers Due to Detection Limits
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
Product
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0304-2019·2018-11-07
Philips Brilliance 64 CT Scanner Software Recall for Misleading Reports
Philips is recalling Brilliance 64 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.
Product
Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0303-2019·2018-11-07
Philips CT Scanner Software Recall for Misleading Calcium Score Reports
Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.
Product
Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

21851–21875 of 40299