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.

10826–10850 of 21617

  • ModerateFDA (Devices)·Z-1345-2018·2018-04-18

    ICU Medical Recalls 7-inch Smallbore Infusion Sets with Incorrect Spin Collar

    ICU Medical is recalling 2,950 sterile 7-inch smallbore infusion sets because they were manufactured with an incorrect spin collar. The affected lots were distributed in the US, Canada, and Japan.

    Product
    7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0624-2018·2018-04-18

    FDA Recalls Zhong Hua Jiu Menthol Patches for GMP Deviations

    United Pacific Co Ltd is recalling Zhong Hua Jiu (menthol 1%) Patches because they were produced with substandard GMP manufacturing processes.

    Product
    Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2018·2018-04-18

    Smith & Nephew Recalls D-RAD Self-Tapping Locking Screws

    Smith & Nephew is recalling D-RAD Self-Tapping Locking Screws because they were machined out of specification. The screws measured over tolerance within the head thread form.

    Product
    D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-1109-2018·2018-04-18

    Diet Pepsi 6-Packs Recalled for Incorrect Aspartame-Free Labeling

    Pepsi Cola Bottling Company is recalling Diet Pepsi 6-packs because the outer packaging incorrectly states the product is 'Now Aspartame Free' when it actually contains aspartame.

    Product
    Diet Pepsi; NOW ASPARTAME FREE; 6 PACK; 16 OZ BOTTLES; 6-16 FLOZ BOTTLES (96 FL OZ)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1306-2018·2018-04-11

    Zimmer Biomet Recalls A.L.P.S. Calcaneus Locking Plate Guide Inserts

    Zimmer Biomet is recalling 22 A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts due to incorrect color anodization.

    Product
    A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1284-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0995-2018·2018-04-11

    Pepsi Recalls Diet Pepsi Cans Due to Incorrect Sweetener Labeling

    Pepsi Beverage Co is recalling 1,972 cases of Diet Pepsi because the cans are labeled to contain Sucralose but actually contain Aspartame.

    Product
    diet Pepsi, 12 FL OZ, in aluminum cans packaged in 12 pk paper cartons
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1277-2018·2018-04-11

    Halyard Health Recalls CORTRAK 2 Nasogastric Feeding Tubes

    Halyard Health is recalling CORTRAK 2 feeding tubes because the internal stylet may be visible in the exit port window, deviating from specifications.

    Product
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0988-2018·2018-04-11

    Ventura Foods Recalls Asian Sesame Ginger Dressing Due to Foreign Material

    Ventura Foods is recalling Gordon Choice Asian Sesame Ginger Dressing because blue plastic bag fragments were found in the product.

    Product
    Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Contenido Neto 128 FL OZ; For Distribution Exclusively By Gordon Food Service Wyoming, MI 49509
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0985-2018·2018-04-11

    Josie's Homestyle Pralines Recalled for Mislabeled Cream and Butter Ingredients

    Josie's Homestyle Pralines are being recalled because the label incorrectly lists cream instead of evaporated milk and omits butter sub-ingredients.

    Product
    Josie's Homestyle #1 Pralines Net Wt. 2 oz (57 g) bag INGREDIENTS: Sugar, Cream, Pecans, Butter, Vanilla, if (Rum) Rum Flavoring. If (Coconut) Coconut. Made By: Josie's Homestyle #1 Pralines, etc. 718 1/2 Filmore St. Kenner, LA 70062 UPC 6 71572 00718 8
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1304-2018·2018-04-11

    Dynavox T10 Speech Generating Device Recalled for Battery Swelling

    Dynavox Systems LLC is recalling 4,615 T10 Speech Generating Devices because the internal battery may swell and cause the device case to separate.

    Product
    Dynavox T10 Speech Generating Device ( including Batteries)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1282-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement.

    Product
    Radial Artery Catheterization Kit; Model: AK-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0618-2018·2018-04-11

    InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE (SR) — BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 930 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life instead of 24 months.

    Product
    Radial Artery Catheterization Kit; Model: AK-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1302-2018·2018-04-11

    GE Healthcare Recalls Centricity PACS-IW Due to Image Data Loss Risk

    GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.

    Product
    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2018·2018-04-11

    Aesculap Recalls DS Titanium Ligation Clip Appliers for Labeling Updates

    Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1313-2018·2018-04-11

    Phadia Recalls ImmunoCAP Allergen c6 Amoxicilloyl Due to Stability Failures

    Phadia US Inc is recalling 950 units of ImmunoCAP Allergen c6, Amoxicilloyl because the product failed to meet stability specifications.

    Product
    ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1286-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling

    Arrow International is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and should be labeled with a 24-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1285-2018·2018-04-11

    Arrow Radial Artery Catheterization Kits Recalled for Shelf Life Labeling Error

    Arrow International is recalling 570 Radial Artery Catheterization Kits because the included povidone iodine prep pads are labeled with an incorrect 36-month shelf life.

    Product
    Radial Artery Catheterization Kit; Model: AK-04122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0619-2018·2018-04-11

    InvaGen Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications during stability testing.

    Product
    BUPROPION HYDROCHLORIDE (SR) — BUPROPION HYDROCHLORIDE (SR) (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2018·2018-04-11

    Mayne Pharma Recalls Fabior Foam Due to Stability Test Failures

    Mayne Pharma is recalling 3,312 cans of Fabior (tazarotene) Foam, 0.1%, because stability testing showed high out-of-specification results for the active ingredient.

    Product
    FABIOR — FABIOR (TAZAROTENE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2018·2018-04-11

    Arrow Arterial Access Tray Recall for Povidone Iodine Shelf Life Labeling

    Arrow International is recalling Arterial Access Trays because the included povidone iodine prep pads do not meet the 36-month shelf life requirement and must be labeled with a 24-month shelf life.

    Product
    Arterial Access Tray, introducer catheter; Model: GU-04020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1301-2018·2018-04-11

    Binding Site Optilite Beta-2-Microglobulin Urine Kit Recalled for Performance Defect

    The Binding Site Group is recalling 20 Optilite Beta-2-Microglobulin Urine Kits because they do not meet the stated antigen excess protection claim.

    Product
    Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1288-2018·2018-04-11

    Southmedic Oxygen Masks Recalled Due to Potential CO2 Diffuser Issues

    Southmedic, Inc. is recalling specific oxygen masks with EtCO2 sampling lines because loose or missing CO2 diffusers may render the masks non-functioning.

    Product
    Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1290-2018·2018-04-11

    Aesculap DS Titanium Ligation Clips Recalled for Contraindication Update

    Aesculap Implant Systems LLC is recalling DS Titanium Ligation Clips to update instructions for use, adding a contraindication for living donor nephrectomies.

    Product
    DS Titanium Ligation Clip, used in laparoscopic surgery
    Category
    Medical Device
    Distribution
    0 states