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.

17751–17775 of 21645

ModerateFDA (Devices)·Z-2711-2014·2014-10-08
Philips Ingenuity CT Scanners Recalled for Image Exposure Mislabeling
Philips Medical Systems is recalling 79 Ingenuity CT scanners because they may mislabel the order of image exposures, potentially affecting clinical interpretation.
Product
The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include…
Category
Medical Device
Distribution
11 states
ModerateFDA (Food)·F-2529-2014·2014-10-08
Goya Pink Beans Recalled for Possible Can Seam Defect
Goya Pink Beans are being recalled due to a possible can seam defect that may compromise product integrity.
Product
Goya Pink Beans In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g)
Category
Food
Distribution
10 states
ModerateFDA (Food)·F-2530-2014·2014-10-08
Goya Black Bean Soup Recalled for Possible Can Seam Defect
Tradewind Foods is recalling Goya Black Bean Soup due to a possible can seam defect that may compromise product integrity.
Product
Goya Black Bean Soup Prepared with Olive Oil, Bell Pepper & Onion 15 oz. (425g)
Category
Food
Distribution
10 states
ModerateFDA (Devices)·Z-2723-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements
Instrumed International is recalling 156 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2725-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 83 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2015·2014-10-08
Gendex eXpertDC Intraoral X-Ray Recall for Spring Link Failures
Gendex Corp is recalling 651 eXpertDC intraoral x-ray units worldwide because spring link components in the articulated arm assembly broke during normal assembly.
Product
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2736-2014·2014-10-08
Nanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk
Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.
Product
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2015·2014-10-08
Ortho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.
Product
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2524-2014·2014-10-08
Goya Whole Green Peas Recalled for Possible Can Seam Defect
Goya Whole Green Peas are being recalled due to a possible can seam defect that may compromise product integrity.
Product
Goya Whole Green Peas Chicharos 15.5 oz (439g)
Category
Food
Distribution
10 states
ModerateFDA (Devices)·Z-2729-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 15 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2735-2014·2014-10-08
Nanosphere Verigene BC-GP Kit Extraction Tray Recall
Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.
Product
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2523-2014·2014-10-08
Goya Black Beans Recalled for Possible Can Seam Defect
Tradewind Foods is recalling Goya Black Beans due to a possible can seam defect that may compromise product integrity.
Product
Goya Black Beans Frijoles Negros 15.5 oz (439g)
Category
Food
Distribution
10 states
ModerateFDA (Food)·F-2532-2014·2014-10-08
Goya Small Red Beans Recalled for Possible Can Seam Defect
Tradewind Foods de Puerto Rico Inc. is recalling Goya Small Red Beans due to a possible can seam defect that may compromise product integrity.
Product
Goya Small Red Beans Habichuelas Coloradas Pequenas 15.5 OZ (439g)
Category
Food
Distribution
10 states
ModerateFDA (Devices)·Z-2716-2014·2014-10-08
Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.
Product
ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0010-2015·2014-10-08
GE Healthcare Precision 500D X-ray Systems Recalled for Missing Screws
GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.
Product
GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2722-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2526-2014·2014-10-08
Goya Chick Peas Recalled for Possible Can Seam Defect
Tradewind Foods de Puerto Rico Inc. is recalling Goya Chick Peas Garbanzos 15.5 oz. due to a possible can seam defect that may compromise product integrity.
Product
Goya Chick Peas Garbanzos 15.5 oz. (439g)
Category
Food
Distribution
10 states
ModerateFDA (Devices)·Z-2732-2014·2014-10-08
Apollo Endosurgery Recalls LAP-BAND AP Systems Distributed Past Expiration
Apollo Endosurgery is recalling 10 LAP-BAND AP Systems distributed past their expiration date in seven states.
Product
LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2721-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 65 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1617-2014·2014-10-08
Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting
Actavis is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol tablets because they may be split or broken.
Product
DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2726-2014·2014-10-08
Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.
Product
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-2531-2014·2014-10-08
Goya Pinto Beans Recalled for Possible Can Seam Defect
Goya Pinto Beans In Sauce are being recalled due to a possible can seam defect that may compromise product integrity.
Product
Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g)
Category
Food
Distribution
10 states
ModerateFDA (Devices)·Z-2719-2014·2014-10-08
St. Jude Medical Percutaneous Trial Lead Kit Manual Recall
St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.
Product
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2717-2014·2014-10-08
KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift
KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.
Product
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2712-2014·2014-10-08
Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect
Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.
Product
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general…
Category
Medical Device
Distribution
40 states