The Recall Desk

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.

12876–12900 of 21617

  • ModerateNHTSA·17V304000·2017-05-04

    Hino 338 Trucks Recalled for Incorrect Certification Labels

    Jim Reed's Truck Sales is recalling 2014-2016 Hino 338 trucks because certification labels fail to identify the final stage manufacturer, potentially hindering safety recall awareness.

    Product
    HINO — HINO 338
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2017·2017-05-03

    XTANT Medical Recalls 5.5mm CoCr Straight Rods Due to Labeling Error

    XTANT Medical Inc. is recalling 97 units of 5.5mm CoCr Straight Rods because the labels may incorrectly identify the material as Ti6Al-4V ELI instead of Cobalt Chromium.

    Product
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2017·2017-05-03

    Ortho VITROS VANC Reagent Recalled for Potential Biased Test Results

    Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.

    Product
    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2142-2017·2017-05-03

    Econo Octopus Style Product Recalled for Squid Mislabeling

    Supermercado Econo Inc. is recalling Econo Estilo Pulpo al Ajillo because the product contains squid but is labeled as octopus.

    Product
    Econo, Estilo Pulpo al Ajillo, Octopus Style with Garlic Flavor, Net Wt. 4oz (115g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1885-2017·2017-05-03

    Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery

    Amendia is recalling 15 units of K-Wires labeled as stainless steel but made of nitinol. The wires were distributed to Georgia, Kansas, and Texas.

    Product
    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1832-2017·2017-05-03

    HeartWare HVAD Pump Driveline Splice Kit Recall for Improved Repair

    Medtronic is notifying clinicians that an improved splice kit is available to replace the HeartWare HVAD Pump Driveline Splice Kit due to a safety issue.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2017·2017-05-03

    Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects

    Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.

    Product
    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2017·2017-05-03

    Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash

    Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.

    Product
    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-2143-2017·2017-05-03

    Econo Octopus Style Marinera Sauce Recalled for Squid Mislabeling

    Supermercado Econo Inc. is recalling Econo Octopus Style Marinera Sauce because the product contains squid but is labeled as octopus.

    Product
    Econo, Estilo Pulpo a la Marinera, Octopus Style Marinera Sauce, Net Wt. 4oz (115g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2137-2017·2017-05-03

    Malgor Recalls Cedeira Octopus Tins Due to Mislabeling

    Malgor & Co. is recalling Cedeira Octopus in Oil Spiced Piquant tins because the label says octopus but the ingredients list jumbo squid.

    Product
    Cedeira Octopus in Oil Spiced Piquant, Net Weight 4.4oz (125g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2145-2017·2017-05-03

    Fresh Express Organic Marketside Spring Mix Recalled for Foreign Animal Matter

    Fresh Express is recalling Organic Marketside Spring Mix because foreign animal matter was allegedly found in a single container. The product was distributed in five states.

    Product
    Organic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1886-2017·2017-05-03

    Stryker SmartLife Large Aseptic Housing Recall for Weld Separation

    Stryker is recalling 302 SmartLife Large Aseptic Housings due to complaints of housing deterioration and weld separation caused by improper cleaning practices.

    Product
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateUSDA FSIS·041-2017·2017-04-27

    Foster Farms Recalls Frozen Breaded Chicken Patties Due to Plastic Contamination

    Foster Farms is recalling approximately 131,880 pounds of frozen breaded chicken patties that may contain pieces of clear, soft plastic.

    Product
    Case Farms, Processing — Foster Poultry Farms Recalls Frozen Ready-To-Eat Breaded Chicken Patty Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0674-2017·2017-04-26

    InnovaGel Recalls Subpotent Diphenhydramine HCl Softgel Capsules

    InnovaGel is recalling approximately 7.9 million subpotent Diphenhydramine HCl 25 mg softgel capsules distributed in New York.

    Product
    Diphenhydramine HCl 25 mg, Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0048P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-2084-2017·2017-04-26

    Sun Opta Recalls Organic Roasted Soy Bits Due to Plastic Contamination

    Sun Opta is recalling specific lots of organic roasted soy bits and splits because pieces of plastic were found in the product.

    Product
    Soy Bits and Soy Splits, Organic, Roasted Not Salted, Individual Super Sac (1450 pounds Soy Bits and 1400 - 1600 pound Soy Splits)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0676-2017·2017-04-26

    Taro Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failures

    Taro Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream because it failed content uniformity specifications during 18-month stability testing.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2017·2017-04-26

    Avid Medical Recalls Vacutainer Tubes Due to Mixed Component Lots

    Avid Medical is recalling 25,308 Vacutainer tubes because an expired component was found in a kit with a later expiration date, leading to incorrect lot and expiration labeling.

    Product
    Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1856-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Orthopedic Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 100 units of D-RAD orthopedic screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2017·2017-04-26

    Verathon Recalls GVL 2 Stat Blades Packaged with Incorrect Size

    Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.

    Product
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2017·2017-04-26

    Merge Healthcare Recalls Eye Station and Eye Care PACS Software

    Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

    Product
    Merge Eye Station and Merge Eye Care PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1857-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Locking Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 197 units of D-RAD locking screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2017·2017-04-26

    Ferno Chair Cot Recalled Due to Incorrect Manufacturing Nut

    Ferno-Washington Inc is recalling 34 units of the PROFlexx Model 28Z Chair Cot because an incorrect nut was used during manufacturing.

    Product
    Ferno PROFlexx¿ Model 28Z Chair Cot
    Category
    Medical Device
    Distribution
    6 states