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.

20776–20800 of 21633

  • ModerateFDA (Devices)·Z-0891-2013·2013-03-06

    Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns

    Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.

    Product
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0881-2013·2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0703-2013·2013-03-06

    GE Healthcare Definium 5000 X-Ray System UI Display Recall

    GE Healthcare is recalling Definium 5000 X-Ray Systems because the user interface may display incorrect exposure settings during rapid protocol switching.

    Product
    GE Healthcare Definium 5000 / 5220493 X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2013·2013-03-06

    GE Healthcare Definium 5000 X-Ray System UI Display Recall

    GE Healthcare is recalling Definium 5000 X-Ray systems because the user interface may display incorrect exposure settings during rapid protocol switching.

    Product
    GE Healthcare Definium 5000/5220493-2 X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-178-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling 27,805 bottles of Citalopram tablets 10mg due to reports of a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0874-2013·2013-03-06

    KY SilkE Vaginal Moisturizer Recalled for Lack of FDA Clearance

    McNeil-PPC is recalling KY SilkE Vaginal Moisturizer because the product is not cleared for marketing in the US.

    Product
    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-171-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0890-2013·2013-03-06

    Oculus Innovative Sciences Recalls Atrapro Antipruritic Hydrogel Due to Preservative Failure

    Oculus Innovative Sciences is recalling Atrapro Antipruritic Hydrogel because stability testing showed insufficient free available chlorine, a preservative required to maintain product safety.

    Product
    Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-179-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling 86,093 bottles of Citalopram tablets due to reports of a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0838-2013·2013-02-27

    Ansell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints

    Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 latex condoms due to complaints about difficulty unrolling and breakage.

    Product
    LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0840-2013·2013-02-27

    Stryker Recalls AC Power Adaptors for Restep DVT System

    Stryker is recalling AC Power Adaptors for the Restep DVT System because wires may come loose, preventing the unit from operating.

    Product
    STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-167-2013·2013-02-27

    Crest Pro-Health Oral Rinse Recalled for Cross-Contamination

    Procter & Gamble is recalling Crest Pro-Health Oral Rinse because it was mixed with another type of mouthwash.

    Product
    Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2013·2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Seals

    ConMed is recalling specific lots of Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-160-2013·2013-02-20

    Upsher Smith Recalls Propranolol Hydrochloride Capsules for Dissolution Failure

    Upsher Smith Laboratories is recalling 60 bottles of Propranolol Hydrochloride Extended-release Capsules, 80 mg, due to failed dissolution test requirements.

    Product
    Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0989-2013·2013-02-20

    Mann Packing Recalls Snap Peas Containing Unapproved Pesticide Carbendazim

    Mann Packing is recalling snap peas found to contain Carbendazim, a pesticide not allowed in the US but approved in the EU.

    Product
    Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated. Product of Guatemala UPC 7 16519 13004 Distributed by Mann Packing, Salinas, CA.
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0813-2013·2013-02-20

    GE Healthcare Recalls Dash Patient Monitors Due to Ethernet Controller Issues

    GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors because an intermittent Ethernet controller defect may cause network connectivity issues.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2013·2013-02-20

    Remel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose

    Remel Inc is recalling 23 units of Oxoid Cefoxitin Antimicrobial Susceptibility Discs because the cartridges may contain discs with an insufficient antibiotic dose.

    Product
    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2013·2013-02-20

    Chenica Wheelchairs Recalled for Crash Test Specification Non-Compliance

    Chenica Inc. is recalling 53 Gunnell Rehab Series wheelchairs because they may not meet WC-19 crash testing specifications.

    Product
    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2013·2013-02-20

    Bacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty

    Bacterin International is recalling expired Osteoselect Demineralized Bone Matrix Putty shipped to customers in Texas, Georgia, and California.

    Product
    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0983-2013·2013-02-13

    Imperial Nuts and Snacks Chocolate and Peanut Platter Recalled for Undeclared Dyes

    Star Snacks Co., LLC is recalling Imperial Nuts and Snacks Chocolate and Peanut Platter because it contains undeclared FD&C colors.

    Product
    Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0765-2013·2013-02-13

    Sybron Endo Lightspeed LSX Files Recalled for Incorrect Length Markings

    Ormco/Sybronendo is recalling specific lots of Lightspeed LSX endodontic files because their length markings are incorrect.

    Product
    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-150-2013·2013-02-13

    West-ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence

    West-ward Pharmaceutical Corp. is recalling 8,585 bottles of Carisoprodol Tablets, USP, 350 mg, due to the presence of uncharacteristic black spots on the tablets.

    Product
    Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-143-2013·2013-02-13

    Actelion Recalls Three Cartons of Subpotent Ventavis Inhalation Solution

    Actelion Pharmaceuticals is recalling three cartons of Ventavis (iloprost) Inhalation Solution due to an out-of-specification assay result indicating the drug was subpotent.

    Product
    Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0789-2013·2013-02-13

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.

    Product
    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
    Category
    Medical Device
    Distribution
    1 state