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.

20226–20250 of 21633

  • ModerateFDA (Drugs)·D-687-2013·2013-07-17

    Sun Pharmaceutical Recalls Nimodipine Capsules Due to Crystallization

    Sun Pharmaceutical Industries Inc. is recalling Nimodipine Capsules 30 mg due to crystallization of the active ingredient.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Vision System Carts

    Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1598-2013·2013-07-17

    Toshiba Kalare Diagnostic X-Ray System Recalled for Image Quality Defect

    Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.

    Product
    TOSHIBA Kalare Diagnostic X-Ray System K110785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Dual Camera Controllers for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1683-2013·2013-07-17

    Baxter Arthroscopic Irrigation Sets Recalled Due to Packaging Pinholes

    Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-787-2013·2013-07-17

    Olympia Pharmacy Recalls Trimix Due to Sterility Concerns

    Olympia Pharmacy is recalling 24 units of compounded Trimix nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Trimix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1644-2013·2013-07-17

    R.L. Schreiber Batter Mix Recalled for Undeclared Red 40

    R.L. Schreiber Inc. is recalling 823 units of Batter Mix because the product contains undeclared Red 40 and does not meet quality specifications for color.

    Product
    R.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case.
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1689-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Instrument Control Boxes

    Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met UL standards due to a malfunctioning test device.

    Product
    da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1629-2013·2013-07-10

    Surgical Instrument Service Recalls Re-New II Endocut Scissor Tips

    Surgical Instrument Service and Savings, Inc. is recalling 10 Re-New II Endocut Scissor Tips because the sterile barrier seal is compromised, allowing the product to fall out of the pouch.

    Product
    - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1628-2013·2013-07-10

    Surgical Instrument Service Recalls Arthroscopic Electrodes Due to Seal Compromise

    Surgical Instrument Service and Savings, Inc. is recalling 447 units of arthroscopic electrodes and wands because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm. Ref. 7205441 Lot 122502 -Acromioplasty Electrode (Grey) 6.5" x 165mm. Ref. C5012A Lot 122288 -CAPSure 30 ArthroWand, CW, 30 Degree Shaft Angle, (Grey) 3.0mm. Ref. AC 1830-01 Lot…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1664-2013·2013-07-10

    SpineFrontier Recalls S-LIFT Instrument Cases Due to Peeling Coating

    SpineFrontier, Inc. is recalling 12 S-LIFT Instrument Cases because a bracket has a peeling nylon coating. The cases are used to hold surgical instruments for spinal fusion.

    Product
    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1582-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Mealtime Due to Coating Defect

    Florida Nutri Labs is recalling 4HB Stack Mealtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1619-2013·2013-07-10

    ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color

    ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.

    Product
    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1659-2013·2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.

    Product
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1645-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920W Event Recorders

    Braemar Inc. is recalling 10,785 lithium thionyl battery packs used with ER920W wireless event monitors following a battery incident that caused no patient injury.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F1583-2013·2013-07-10

    Florida Nutri Labs Recalls 4HB Stack Bedtime Due to Swallowing Difficulty

    Florida Nutri Labs is recalling 4HB Stack Bedtime caplets because they were not coated, making them difficult to swallow.

    Product
    "***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1639-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Relieva Flex Sinus Guide Catheter

    Surgical Instrument Service And Savings, Inc. is recalling Relieva Flex Sinus Guide Catheter and Luma Sentry 20 Tip Angle products because the sterile barrier seal may be compromised.

    Product
    - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument for general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1637-2013·2013-07-10

    TPS Micro Reciprocating Rasp Recalled Due to Compromised Sterile Seal

    Surgical Instrument Service And Savings, Inc. is recalling four units of TPS Micro Reciprocating Small Tear Cross Cut Rasps because the sterile barrier seal may be compromised.

    Product
    TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Scorpion Needles Due to Seal Compromise

    Surgical Instrument Service And Savings, Inc. is recalling specific lots of Scorpion Needles and Suture Passing Wires because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot 123263 -SureFire Scorpion Needle (purple). Ref. AR-13991N Lot 123263 and 122279 -Suture Passing Wire. Ref. AR-1255-18 Lot 123190 Manual surgical instrument for general use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-638-2013·2013-07-10

    Diazepam 5 mg/ml Recalled for Lack of Sterility Assurance

    Clinical Specialties Compounding Pharmacy is recalling Diazepam 5 mg/ml due to FDA inspection findings regarding quality control and lack of sterility assurance.

    Product
    Diazepam 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1632-2013·2013-07-10

    Barron Radial Vacuum Trephine Set Recalled Due to Compromised Sterile Seal

    Surgical Instrument Service and Savings, Inc. is recalling Barron Radial Vacuum Trephine Sets because the sterile seal may be compromised, allowing product to fall out of the pouch.

    Product
    Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1626-2013·2013-07-10

    Surgical Suture Recall Due to Compromised Sterile Barrier Seal

    Surgical Instrument Service and Savings, Inc. is recalling GII QuickAnchor Plus sutures because the sterile barrier seal may be compromised, allowing product to fall out of the pouch.

    Product
    GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1642-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Phacofragmentation System Tips

    Surgical Instrument Service And Savings, Inc. is recalling specific phacofragmentation system tips because the sterile barrier seal became compromised, allowing the product to fall out of the pouch.

    Product
    - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared ABS¿ Tip, 20 Degree Tip Angle, 45¿ Kelman, (Purplish Pink/Silver) 0.9mm Ref. 8065750853 Lot 122590, 123372 - TurboSonics¿ Tapered ABS¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2013·2013-07-10

    Surgical Instrument Recall Due to Compromised Sterile Seal

    Surgical Instrument Service And Savings is recalling Large Tear Cross Cut Rasps because the sterile seal may be compromised, allowing the product to fall out of the pouch.

    Product
    Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1623-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Carpal Tunnel Release Blades

    Surgical Instrument Service And Savings, Inc. is recalling specific carpal tunnel release blades and kits because the sterile barrier seal was compromised, potentially allowing product to fall out of the pouch.

    Product
    -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release…
    Category
    Medical Device
    Distribution
    Distributed nationwide