Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

12001–12025 of 21617

ModerateFDA (Devices)·Z-2881-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS MIS Poly Screw Driver B
Valorem Surgical LLC is recalling 2,225 units of the Pallas M/MAXIMIS MIS Poly Screw Driver B because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Poly Screw Driver B. 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-2877-2017·2017-08-16
Valorem Surgical Recalls Pallas M Crosslink Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Small Crosslink devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Small Crosslink. 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-2890-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 40mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 40mm 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-2964-2017·2017-08-16
Valorem Surgical Recalls Pallas M Wall Check Spinal Fixation Devices
Valorem Surgical LLC is recalling Pallas M/MAXIMIS Wall Check devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Wall Check. 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-2948-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Straight Rods for Quality Issues
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 40mm Straight Rods because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 40mm Straight 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-3005-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS MIS Anti Torque Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS MIS Anti Torque devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Anti Torque. 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-2878-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Large Crosslink Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Large Crosslink devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Large Crosslink. 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-2931-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screw Spinal Fixation Devices
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 5.5 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-2826-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 1 CC TB 27 G X 0.5, 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2962-2017·2017-08-16
Valorem Surgical Recalls Pallas M Tapper Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Tapper 5.5 spinal fixation devices due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Tapper 5.5. 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-2974-2017·2017-08-16
Valorem Surgical Recalls Pallas M Inside Bender Spinal Fixation Devices
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Inside Bender devices due to quality system non-compliance.
Product
PALLAS M/MAXIMIS Inside Bender (L) and (R). 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-2814-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling hypodermic needles because documentation supporting sterility claims is insufficient. The recall covers 54,204,100 units distributed nationwide.
Product
Hypodermic Needle, 22 G X 1.0 in 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 or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2960-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 500mm Straight Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 500mm Straight Rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 500mm Straight 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-2837-201·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2952-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Straight Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 70mm Straight 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-3009-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS S. Spinal Fixation Probes
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS S. probes used in spinal fixation systems because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS S. Probe. 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-2905-2017·2017-08-16
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 Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly Screw 7.5 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-2901-2017·2017-08-16
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 Quality System Requirements.
Product
PALLAS M/MAXIMIS Poly 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-2887-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 60mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm MIS Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm 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-3012-2017·2017-08-16
Valorem Surgical Recalls Pallas M Driver Shaft for Quality System Non-Compliance
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Driver Shafts because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2963-2017·2017-08-16
Valorem Surgical Recalls Pallas M Tapper for Quality System Non-Compliance
Valorem Surgical LLC is recalling Pallas M/MAXIMIS Tapper 6.5 devices because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Tapper 6.5. 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-2831-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2943-2017·2017-08-16
Valorem Surgical Recalls Pallas M Spinal Fixation Rods
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 50mm spinal fixation rods due to quality system non-compliance. The devices are distributed nationwide in the US.
Product
PALLAS M/MAXIMIS 50mm Curved and precontoured 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-2879-2017·2017-08-16
Valorem Surgical Recalls Pallas M Curved Rods for Quality System Non-Compliance
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 5.5 x 05mm Curved Rods because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 5.5 x 05mm Curved 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-2875-2017·2017-08-16
Valorem Surgical Recalls Pallas M 60mm Curved Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm Curved Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm Curved 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