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.

16076–16100 of 21645

  • ModerateFDA (Food)·F-2888-2015·2015-08-05

    Dairy Farmers of America Recalls Borden Grilled Cheese Melts for Plastic Film

    Dairy Farmers of America is recalling Borden Grilled Cheese Melts because a piece of plastic film might remain attached to the cheese slice.

    Product
    Pasteurized Prepared Cheese Product: .BORDEN 12/10.67OZ GRILLED CHEESE MELTS YLW PP2.99, 5300000429. BORDEN 12/12OZ GRILLED CHEESE MELTS YLW, 5300000436. BORDEN 48/12 OZ GRILLED CHEESE MELTS , 5300000436.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Food)·F-2876-2015·2015-08-05

    Dairy Farmers of America Recalls Fat-Free Cheese Products Due to Plastic Film

    Dairy Farmers of America is recalling specific fat-free cheese products because a piece of plastic film strip might remain attached to the cheese slice.

    Product
    Non-Fat Pasteurized Prepared Cheese Product: FOOD CLUB 12/12OZ AMER FAT FREE YELLOW, 3680045432. SHOPPRITE 12/12OZ AMER FAT FREE YLW, 4119045837. MEIJER 12/12 OZ AMERICAN FAT FREE COLOR, 4125056702. SCHNUCKS 12/12OZ AMER FAT FREE YLW, 4131858109.
    Category
    Food
    Distribution
    39 states
  • ModerateUSDA FSIS·107-2015·2015-08-03

    Land O'Frost Recalls Beef Summer Sausage Due to Undeclared Pork

    Land O'Frost is recalling 12 oz. packages of Ambassador Beef Summer Sausage because the product contains pork that is not declared on the label.

    Product
    Land O' Frost — Land O'Frost Recalls Sausage Product Due to Misbranding
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2160-2015·2015-07-29

    FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 550 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2015·2015-07-29

    FDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Sure F!ex laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1254-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA LLC is recalling 491,360 bottles of Zonisamide Capsules, 100 mg, because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1260-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling specific lots of Lisinopril 30 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2151-2015·2015-07-29

    Gardner Denver Thomas Recalls Medi-Pump Aspirators Due to Performance Issues

    Gardner Denver Thomas is recalling 508 Medi-Pump aspirators because the vacuum pump may not perform to specification.

    Product
    THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2172-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2098-2015·2015-07-29

    CooperSurgical Recalls Milex Vaginal-Hymenal Silicone Dilators Due to Labeling Error

    CooperSurgical is recalling 40 kits of Milex Vaginal-Hymenal Silicone Dilators because the outer carton labels contain an incorrect expiration date.

    Product
    Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1276-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Captopril 50 mg tablets because the manufacturer did not adequately investigate customer complaints.

    Product
    Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 910¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2148-2015·2015-07-29

    EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure

    EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.

    Product
    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1273-2015·2015-07-29

    Wockhardt Recalls Zonisamide Capsules Due to Complaint Investigation Failures

    Wockhardt USA is recalling 84,542 bottles of Zonisamide 50 mg capsules because the firm did not adequately investigate customer complaints.

    Product
    Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1258-2015·2015-07-29

    Wockhardt Recalls Lisinopril Tablets Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling Lisinopril 10 mg tablets because the firm did not adequately investigate customer complaints. The recall covers multiple lot numbers distributed nationwide.

    Product
    Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1265-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling Famotodine Tablets 20 mg because the company did not adequately investigate customer complaints, a CGMP deviation.

    Product
    Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1269-2015·2015-07-29

    Wockhardt Recalls Lansoprazole Capsules Due to Inadequate Complaint Investigation

    Wockhardt USA is recalling specific lots of Lansoprazole Delayed-Release Capsules because the manufacturer did not adequately investigate customer complaints.

    Product
    Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counters Recalled for Barcode Label Error

    Perkinelmer is recalling 54 WIZARD2 gamma counters worldwide due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1271-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1246-2015·2015-07-29

    Wockhardt Recalls Extended Phenytoin Sodium Capsules Due to CGMP Deviations

    Wockhardt USA is recalling 53,894 bottles of Extended Phenytoin Sodium Capsules because the firm did not adequately investigate customer complaints.

    Product
    Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2015·2015-07-29

    Siemens Recalls ADVIA Centaur Tni-Ultra Assay Due to System Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Tni-Ultra Assay kits due to system-to-system bias between different ADVIA Centaur platforms.

    Product
    ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2015·2015-07-29

    Cook Inc. Recalls Flexor RTPS Guiding Sheaths Due to Dilator Length Complaints

    Cook Inc. is voluntarily recalling Flexor RTPS Guiding Sheaths and Ring Transjugular Intrahepatic Access Sets because users reported the included dilators were too long.

    Product
    Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2157-2015·2015-07-29

    FDA Recalls Sureflex 200 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 200 Lithotripsy Fibers because validation data for cleaning and sterilization methods does not meet FDA guidance for reusable products.

    Product
    Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1248-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA Inc. is recalling Azithromycin Tablets, USP, 250 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by…
    Category
    Drug
    Distribution
    Distributed nationwide