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.

12076–12100 of 21617

ModerateFDA (Devices)·Z-2820-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 27 G X 0.5 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-2855-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 10 cc piston syringes because the company lacks sufficient documentation to support the products' sterility claims.
Product
Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/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-2916-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling Pallas M/MAXIMIS MIS Pedicle Screws because the devices are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2836-201·2017-08-16
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 nationwide because of insufficient documentation to support sterility claims.
Product
Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 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-2860-2017·2017-08-16
FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling 30 CC L/S Piston Syringes because the company lacks sufficient documentation to support the product's sterility claims.
Product
Piston Syringe, 30 CC L/S, 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-2980-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Dilator B Spinal Fixation Components
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Dilator B components due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS Dilator 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-2942-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 45mm Curved Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 45mm Curved Rods due to quality system non-compliance. The devices are part of a spinal fixation system.
Product
PALLAS M/MAXIMIS 45mm 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-2818-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Product
Hypodermic Needle, 25 G X 1.5 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-3007-2017·2017-08-16
Valorem Surgical Recalls Pallas M Head Holders for Quality Issues
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Head Holders because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS Head Holder. 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-2882-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 30mm Spinal Fixation Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30mm rods due to quality system non-compliance. The devices are distributed nationwide in the US.
Product
PALLAS M/MAXIMIS 30mm 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-2885-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 45mm MIS pedicle screws because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 45mm MIS . 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-2926-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 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-2921-2017·2017-08-16
Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 7.5 x 50mm pedicle screws because they are not consistent with FDA Quality System Requirements.
Product
PALLAS M/MAXIMIS 7.5 x 50mm 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 spine.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2939-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 30 mm Curved Rods
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 30 mm Curved Rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 30 mm 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-2891-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 35mm MIS Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm MIS Rods because they are not consistent with Quality System Requirements.
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-2854-2017·2017-08-16
International Medsurg Piston Syringes Recalled for 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, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/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-2955-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 35mm Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 35mm 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-2944-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 60mm Spinal Fixation Rods
Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS 60mm curved and precontoured rods due to non-compliance with Quality System Requirements.
Product
PALLAS M/MAXIMIS 60mm 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-2849-2017·2017-08-16
FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues
International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support product sterility claims.
Product
Piston Syringe and Hypodermic Needle, 10 CC L/L 22 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
ModerateFDA (Food)·F-3359-2017·2017-08-16
ISABEL Octopus in Garlic Sauce Recalled for Mislabeling as Squid
ISABEL North America is recalling Octopus in Garlic Sauce because the label states Octopus but the actual content is Squid.
Product
ISABEL, Octopus in garlic sauce, Pulpo al ajillo, Net wt - Peso Neto 4 oz(115g)
Category
Food
Distribution
0 states
ModerateFDA (Devices)·Z-2884-2017·2017-08-16
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-2858-2017·2017-08-16
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 product sterility claims.
Product
Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/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-2819-2017·2017-08-16
FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation
International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.
Product
Hypodermic Needle, 25 G X 5/8 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-2935-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues
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 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-2957-2017·2017-08-16
Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm Rods because they are not consistent with Quality System Requirements.
Product
PALLAS M/MAXIMIS 40mm 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