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.

15126–15150 of 21645

ModerateFDA (Devices)·Z-1075-2016·2016-03-16
Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.
Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0639-2016·2016-03-16
Strawberry Wafers Recalled for Undeclared Food Dyes
Dollar Only Wholesale is recalling Strawberry Wafers because they may contain undeclared FD&C Red #3 and Yellow #6.
Product
8pk Strawberry Waffy Wafers, Global Brands item UPC 876274000806 BB 8/14/16 20142nj, BB 10/27/16 20145nj
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1070-2016·2016-03-16
Conformis iTotal Knee Replacement System Recalled for Incorrect Component
ConforMIS, Inc. is recalling a specific unit of the iTotal Cruciate Retaining Knee Replacement System because an incorrect femoral component was distributed.
Product
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1049-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 817 CT and PET CT scanner systems worldwide because service manuals contained incorrect torque values.
Product
Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1051-2016·2016-03-16
GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values
GE Medical Systems is recalling 324 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.
Product
LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body…
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1020-2016·2016-03-09
Philips Recalls BrightView Gamma Cameras Due to Motion and Collision Issues
Philips Medical Systems is recalling 677 BrightView gamma cameras because the collimator may contact the patient pallet or the gantry may halt prematurely during scans.
Product
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0697-2016·2016-03-09
Smith's Country Cheese-Gouda with Bacon Spread Recalled for Non-Pathogenic E. Coli
Smith's Country Cheese, Inc. is recalling 8 oz. containers of Gouda with Bacon Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Smith's Country Cheese-Gouda with Bacon Spread packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1034-2016·2016-03-09
FDA Recalls Mispackaged Pediatric Feeding Tubes from Covidien
The FDA is recalling 1,330 units of pediatric feeding tubes due to packaging errors where different tube sizes were placed in incorrect packages.
Product
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·F-0693-2016·2016-03-09
Smith's Creamy Gouda Spread Recalled for Non-Pathogenic E. Coli
Smith's Country Cheese is recalling Creamy Gouda Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Smith's Country Cheese -Creamy Gouda Spread packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1043-2016·2016-03-09
Aesculap Recalls Mislabelled Knee Implant Packaging for Cementless Use
Aesculap Inc. is recalling 1,232 units of Columbus Revision and EnduRo Knee System packaging labeled as cementless, which are indicated for use with bone cement only.
Product
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0735-2016·2016-03-09
Sun Pharma Recalls Alendronate Sodium Tablets Due to Impurity Levels
Sun Pharma Global Fze is recalling specific lots of Alendronate Sodium Tablets 70 mg because unknown impurity levels exceeded specifications during stability testing.
Product
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1032-2016·2016-03-09
Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error
Novadaq is recalling 110 PINPOINT Endoscopic Fluorescence Imaging Systems because the operator's manual lacks validated sterilization parameters for specific components.
Product
PINPOINT Endoscopic Fluorescence Imaging System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1039-2016·2016-03-09
Stryker AccuPlace Drace Stereotaxic Needle Guide Recalled for Packaging Sterility Risk
Stryker is recalling AccuPlace Drace Stereotaxic Needle Guides because packaging defects may breach sterility. The recall covers 5,800 units distributed nationwide.
Product
50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1038-2016·2016-03-09
Stryker AccuPlace Round Level Needle Guide Recalled for Sterility Breach Risk
Stryker is recalling AccuPlace Round Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Product
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0698-2016·2016-03-09
Smith's Country Cheese Gouda with Horseradish Spread Recalled for E. Coli
Smith's Country Cheese is recalling 8 oz. containers of Gouda with Horseradish Spread due to non-pathogenic E. Coli contamination.
Product
Smith's Country Cheese-Gouda with Horseradish Spread packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0695-2016·2016-03-09
Smith's Country Cheese Gouda Spread Garlic Recalled for E. Coli
Smith's Country Cheese is recalling Gouda Spread Garlic due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Smith's Country Cheese -Gouda Spread Garlic packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1041-2016·2016-03-09
Volcano R-100 Sterile Equipment Covers Recalled for Incorrect Expiry Date Labeling
Volcano Corporation is recalling R-100 Sterile Equipment Covers because the outer shipping boxes may display incorrect expiry dates, although the inner product is correctly labeled.
Product
Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0700-2016·2016-03-09
Smith's Country Cheese Gouda Spread Recalled for Non-Pathogenic E. Coli
Smith's Country Cheese is recalling Gouda with Onion and Chive Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Smith's Country Cheese-Gouda with with Onion and Chive Spread packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Devices)·Z-1023-2016·2016-03-09
Medtronic Perfusion Tubing Packs Recalled Due to Cuvette Safety Alert
Medtronic is recalling specific lots of Perfusion Tubing Packs because they contain Terumo CVS cuvettes subject to an Urgent Safety Alert.
Product
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This…
Category
Medical Device
Distribution
24 states
ModerateFDA (Devices)·Z-1037-2016·2016-03-09
Stryker AccuPlace Needle Guide Recalled for Sterility Breach Risk
Stryker is recalling AccuPlace Straight Level Needle Guides because packaging defects may compromise sterility. The recall affects 5,800 units distributed nationwide.
Product
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0692-2016·2016-03-09
Smith's Gouda Cheese Recalled for Non-Pathogenic E. Coli Contamination
Smith's Country Cheese is recalling specific lots of Gouda cheese due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Gouda Cheese packaged under the brand names: Smith's Farmstead Gouda and Jansal Valley Mountain Gouda, Packaged in 11 lb. waxed wheel in saran wrap. 5 lb. Half wheels wrapped in shrink pack packaging.
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0694-2016·2016-03-09
Smith's Country Cheese Creamy Gouda Recalled for Non-Pathogenic E. Coli
Smith's Country Cheese is recalling Creamy Gouda with Wine Spread due to contamination with non-pathogenic E. Coli. The product was distributed in Georgia, New Hampshire, and Massachusetts.
Product
Smith's Country Cheese- Creamy Gouda with Wine Spread packaged in 8 oz. plastic container
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0702-2016·2016-03-09
Nutrifruit Freeze Dried Black Raspberry Powder Recalled for Labeling Error
Scenic Fruit Company is recalling Nutrifruit Freeze Dried Black Raspberry Powder because the label incorrectly states 0 grams of sugar per serving instead of 2 grams.
Product
Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00019 0.
Category
Food
Distribution
6 states
ModerateFDA (Devices)·Z-1036-2016·2016-03-09
Medical Action Industries Recalls PICC/CVC Dressing Kits Due to Misbranding
Medical Action Industries is recalling 180 PICC/CVC Secure Dressing Change kits because the presence of CHG is not identified on the exterior labeling.
Product
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0701-2016·2016-03-09
Scenic Fruit Company Recalls Freeze Dried Mango Powder Due to Label Error
Scenic Fruit Company is recalling 331 units of Nutrifruit brand Freeze Dried Mango Powder because the label incorrectly lists 625.7 grams of carbohydrates per serving instead of 6 grams.
Product
Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4.
Category
Food
Distribution
6 states