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.

19451–19475 of 21751

  • ModerateFDA (Devices)·Z-0620-2014·2014-01-08

    GE Centricity Laboratory System Recall for Free-Text Data Loss

    GE Healthcare is recalling 5 units of the Centricity Laboratory System because free-text data from instruments may be discarded if orders are not yet in the system.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0593-2014·2014-01-08

    Philips HeartStart MRx Monitor/Defibrillator Recall for Labeling Error

    Philips is recalling 93 HeartStart MRx Monitor/Defibrillators because the first therapy energy setting is mislabeled as 10 instead of 1-10.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0609-2014·2014-01-08

    Zimmer Recalls Reverse Glenosphere and Other Devices Due to Packaging Error

    Zimmer is recalling specific lots of medical devices because they were packaged in incorrect outer cartons, though the product labels are correct.

    Product
    Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-1341-2014·2014-01-08

    Nestle Recalls Joseph's Asiago and Garlic Tortelloni for Foreign Material

    Nestle Prepared Foods is recalling specific lots of Joseph's Asiago and Garlic Tortelloni due to a potential for foreign material. The product was distributed in New York, Georgia, and Pennsylvania.

    Product
    Joseph's Gourmet Pasta and Sauces- Asiago and Garlic Tortelloni (par cooked). Sold Frozen in 5 lb. plastic bags for food service Item Number: 22273 (G11008331) UPC Code: 00048769222738
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1366-2014·2014-01-08

    Lotus Foods Recalls Organic Millet and Brown Rice Ramen Due to Mold

    Lotus Foods is recalling 8,568 bags of Organic Millet & Brown Rice Ramen due to a customer complaint of mold. The product was distributed in California, New Hampshire, and Texas.

    Product
    Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan Ready in 4 minutes; Net Wt. 10 oz; (283g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1355-2014·2014-01-08

    Adelphia Seafood Shrimp Salad Recalled for Undeclared Red Dye 40

    Hahn, Harry O Seafood Inc is recalling Adelphia Seafood Shrimp Salad because Red #40 color additive was not declared on the label.

    Product
    Adelphia Seafood Shrimp Salad, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA, Ingredients: shrimp, celery, mayonnaise, onion, green pepper, relish, sweet pickle, chili sauce (sugar, water, picked red chili, vinegar, garlic, salt, stabilizer, xanthan gum), gum cellulose.…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0616-2014·2014-01-08

    Steris SYSTEM 1E Liquid Chemical Sterilant Processing System Recalled for Valve Issues

    Steris Corporation is recalling SYSTEM 1E Liquid Chemical Sterilant Processing Systems because check valve o-rings degrade, causing nuisance aborts.

    Product
    SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1353-2014·2014-01-08

    Kirkman Biofilm Defense Recalled for Potential Chloramphenicol Contamination

    Kirkman Group Inc. is recalling Biofilm Defense dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1349-2014·2014-01-08

    Kirkman EnZym-Complete Dietary Supplements Recalled for Chloramphenicol Contamination

    Kirkman Group Inc. is recalling specific EnZym-Complete dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.

    Product
    EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0610-2014·2014-01-08

    Zimmer Recalls Hip and Shoulder Devices Packaged in Incorrect Cartons

    Zimmer is recalling specific lots of hip and shoulder devices due to incorrect outer packaging. Product labels are correct, but the outer cartons were wrong.

    Product
    Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal…
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Food)·F-0816-2014·2014-01-08

    XYMOGEN Recalls LipiChol 540 Medical Food Due to Mislabeling

    Atlantic Pro Nutrients is recalling LipiChol 540 because it was labeled as a medical food instead of a dietary supplement.

    Product
    LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-396-2014·2014-01-08

    Teva Recalls Niacin Extended Release Tablets Due to Broken Tablets

    Teva Pharmaceuticals is recalling Niacin Extended Release Tablets, 500 mg, because the tablets may be broken.

    Product
    Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1357-2014·2014-01-08

    Adelphia Seafood Mermaid Salad Recalled for Undeclared Red #40 Color Additive

    Hahn, Harry O Seafood Inc is recalling Adelphia Seafood Mermaid Salad because the shrimp ingredient contains Red #40, which is not declared on the label.

    Product
    Adelphia Seafood Mermaid Salad in a 5 lb. plastic tub. Ingredients: surimi (alaska pollock, water, wheat flour, soybean oil, natural and artificial flavor), shrimp, pasta shell, mayonnaise (vegetable oil (soybean, canola), egg yolk, water, corn syrup, vinegar), lemon juice…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1365-2014·2014-01-08

    Lotus Foods Recalls Organic Jade Pearl Rice Ramen Due to Mold Complaint

    Lotus Foods is recalling Organic Jade Pearl Rice Ramen after a customer complaint of mold. The recall affects 8,496 bags distributed in California, New Hampshire, and Texas.

    Product
    Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) ramen per bag USDA Organic; Lotus Foods, Richmond, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0615-2014·2014-01-08

    Synthes Electric Pen Drive Hand Switch Recalled for Labeling Error

    Synthes USA HQ, Inc. is recalling 290 Electric Pen Drive Hand Switches because the 'on' and 'lock' labels were interchanged.

    Product
    Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1356-2014·2014-01-08

    Adelphia Seafood Shrimp & Scallop Rotini Recalled for Undeclared Red Dye

    Hahn, Harry O Seafood Inc is recalling Adelphia Seafood Shrimp & Scallop Rotini because Red #40 color additive in the shrimp was not declared on the label.

    Product
    Adelphia Seafood Shrimp & Scallop Rotini, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA. Ingredients: pasta, oil (soybean and olive), cider vinegar, water, shrimp, scallops, red & green peppers, red onion, food starch, salt, spices, natural preservatives. Allergens…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0606-2014·2014-01-08

    RTC 25-C Inline Aerosol Tee Adapter Recalled for Incomplete Instructions

    Instrumentation Industries Inc. is recalling 220 units of the RTC 25-C Inline Aerosol Tee Adapter because some packages were shipped with incomplete installation and usage directions due to a printing error.

    Product
    RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1364-2014·2014-01-08

    Lotus Foods Recalls Organic Forbidden Rice Ramen Due to Mold Complaint

    Lotus Foods is recalling 8,568 bags of Organic Forbidden Rice Ramen following a customer complaint of mold. The product was distributed in California, New Hampshire, and Texas.

    Product
    Organic Forbidden RICE RAMEN; Gluten Free/Vegan, Black Rice Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1347-2014·2014-01-08

    Kirkman EnZym-Complete Recall Due to Potential Chloramphenicol Contamination

    Kirkman Group Inc. is recalling specific bottles of EnZym-Complete/DPPIV with Isogest because they may contain chloramphenicol above the allowed limit.

    Product
    Chewable EnZym-Complete/DPPIV with Isogest, Kirkman brand. Item # 0934-090.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1367-2014·2014-01-08

    Lotus Foods Recalls Forbidden Rice Ramen Due to Mold Complaint

    Lotus Foods is recalling 18,000 bags of Forbidden Rice Ramen with miso soup due to a customer complaint of mold. The product was distributed in California, New Hampshire, and Texas.

    Product
    Forbidden RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-393-2014·2014-01-08

    Sandoz Recalls Subpotent Fosinopril Sodium and Hydrochlorothiazide Tablets

    Sandoz Inc. is recalling specific lots of Fosinopril Sodium and Hydrochlorothiazide tablets because the hydrochlorothiazide content was subpotent at the 9-month time point.

    Product
    Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1369-2014·2014-01-08

    Lotus Foods Recalls Millet and Brown Rice Ramen Due to Mold Complaint

    Lotus Foods is recalling Millet & Brown Rice Ramen with miso soup after a customer complaint of mold. The recall covers 18,000 bags distributed in California, New Hampshire, and Texas.

    Product
    Millet & Brown RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA.
    Category
    Food
    Distribution
    3 states