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

25876–25900 of 40233

ModerateFDA (Devices)·Z-2920-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS pedicle screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2861-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 60 CC piston syringes because the company lacks documentation to support the products' sterility claims.
Product
Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2893-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2913-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3004-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS I Handle for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS I Handles because they do not meet FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2988-2017·2017-08-16
Valorem Surgical Recalls Pallas M Extension Drivers for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Extension Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2889-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 80mm MIS Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm MIS Rods due to inconsistencies with Quality System Requirements.
Product
PALLAS M/MAXIMIS 80mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2986-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Closed Extension Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Closed Extension devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Closed Extension. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2851-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million piston syringes because documentation supporting their sterility claims is insufficient.
Product
Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2978-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Dilator Handles for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Dilator Handles because they are not consistent with Quality System Requirements. The devices are part of a spinal fixation system.
Product
PALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2900-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2883-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 35mm MIS Rods
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 35mm MIS rods due to quality system non-compliance. The devices are used for spinal fixation.
Product
PALLAS M/MAXIMIS 35mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2934-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2922-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2961-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Awl for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Awls because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2925-2017·2017-08-16
Valorem Surgical Recalls MAXIMIS Pedicle Screws for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 units of MAXIMIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2850-2017·2017-08-16
International Medsurg Piston Syringes Recalled for Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2806-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million hypodermic needles because documentation supporting their sterility claims is insufficient.
Product
Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2859-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2928-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3011-201·2017-08-16
Valorem Surgical Recalls Pallas M Body Alignment Drivers for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Body Alignment Drivers because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3015-2017·2017-08-16
Valorem Surgical Recalls Pallas M Guide Wires for Quality System Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Guide Wires because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2984-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Extensions
Valorem Surgical is recalling 262 Pallas M/MAXIMIS Open Extension (Small) devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2805-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 16-gauge hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.
Product
Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2845-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
Category
Medical Device
Distribution
Distributed nationwide

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25876–25900 of 40233