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.

21351–21375 of 21633

  • ModerateFDA (Devices)·Z-2209-2012·2012-08-22

    Roche Recalls COBAS AmpliPrep Sample Tube Input Barcode Clips

    Roche Molecular Systems is recalling certain lots of COBAS AmpliPrep barcode clips because they can cause sample tubes to stick, leading to aborted instrument runs.

    Product
    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2211-2012·2012-08-22

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DGXN Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DGXN Slides because the Instructions for Use were revised to remove heparin plasma as a recommended specimen type.

    Product
    VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2183-2012·2012-08-22

    Beauty Angel Device Recalled for Lack of FDA Clearance

    JK Products & Services is recalling Beauty Angel devices because they were marketed without the required FDA 510(k) clearance.

    Product
    BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1646-2012·2012-08-22

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Scalp Oil

    Hill Dermaceuticals is recalling 161,064 bottles of Derma-Smoothe/FS scalp oil because the product is subpotent, meaning it contains less of the active ingredient than labeled.

    Product
    Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2012·2012-08-22

    SenTec Recalls V-Sign 2 Sensors Due to Configuration Parameter Writing Errors

    Sentec AG is recalling V-Sign 2 Sensors because of a problem with configuration parameter writing during manufacturing.

    Product
    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2012·2012-08-15

    Abbott i-Stat cTnl Cartridges Recalled Due to Atmospheric Pressure Effects

    Abbott Point of Care Inc. is recalling i-Stat cTnl cartridges because atmospheric pressure affects the frequency of suppressed results.

    Product
    i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2161-2012·2012-08-15

    Straumann Dental Implant Screw Recall Due to Incorrect Component

    Straumann USA is recalling 14 dental implant sets because the included screw was not the correct Narrow CrossFit model.

    Product
    Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1688-2012·2012-08-15

    Itoen Green Tea Recalled Due to Unretorted Product Release

    Itoen (USA) Inc. is recalling Itoen Green Tea cans because unretorted product was inadvertently released for distribution in California.

    Product
    Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road Honolulu, HI 96819
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2145-2012·2012-08-15

    Smith & Nephew Dyonics Bonecutter Recalled for Incorrect Expiry Labeling

    Smith & Nephew is recalling 108 units of the 5.5 mm Dyonics Bonecutter because the devices are labeled with a 48-month expiry instead of the validated 36-month period.

    Product
    Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2147-2012·2012-08-15

    ConMed Linvatec Recalls CrossFT Punch Due to Incorrect Etching

    ConMed Linvatec is recalling 2 units of the CrossFT Punch (Lot #156920) because the device may have incorrect item numbers and depth lines.

    Product
    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2012·2012-08-15

    Afassco Multi-Colored Finger Cots Recalled for Missing Latex Warning Label

    Afassco Inc. is voluntarily correcting a field issue for multi-colored finger cots that lack the required natural rubber latex warning label.

    Product
    The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2143-2012·2012-08-15

    SCC Soft Computer Recalls SoftLab Laboratory Information System Software

    SCC Soft Computer is correcting SoftLab software versions that incorrectly displayed results from two different Sysmex hematology instruments under a single order.

    Product
    SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2180-2012·2012-08-15

    AngioDynamics Recalls Soft-Vu Angiographic Catheters Due to Mislabeled Pouches

    AngioDynamics is recalling one lot of Soft-Vu angiographic catheters because a pouch inside the box may be mislabeled.

    Product
    AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1858-2012·2012-08-15

    Naturex Recalls Dried Brewers Yeast Due to High Selenium Levels

    Naturex Inc. is recalling specific lots of Dried Brewers Yeast because testing found unusually high levels of selenium. The product was distributed to two firms in New Jersey and South Carolina.

    Product
    Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1929-2012·2012-08-15

    Great American Seafood Cooked Shrimp Meat Recalled for Undeclared Dyes

    Southwind Foods is recalling cooked shrimp meat because it contains undeclared red #40 and yellow #6 colors.

    Product
    Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2012·2012-08-15

    Radiometer ABL800 Software Recall for HL7 Data Transmission Errors

    Radiometer America is recalling ABL800 software version 6.12 because HL7 2.5 configuration errors may cause queued blood test results to be mixed up when transmitted to hospital systems.

    Product
    The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2012·2012-08-15

    Smith & Nephew Dyonics Electroblade Resector Recalled for Labeling Error

    Smith & Nephew is recalling Dyonics Electroblade Resectors labeled with an incorrect 48-month expiry date instead of 36 months.

    Product
    Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2156-2012·2012-08-15

    Philips MultiDiagnost Eleva X-ray System Recalled for 3D Reconstruction Failure

    Philips Healthcare Inc. is recalling 41 units of the MultiDiagnost Eleva X-ray system because the 3D reconstruction feature may fail to start during rotational angiography.

    Product
    Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2012·2012-08-15

    Radiometer ABL Software Recall for HL7 Data Transmission Errors

    Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.

    Product
    The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1443-2012·2012-08-15

    Apotex Recalls Meloxicam Tablets Due to Slightly Oversized Tablet

    Apotex Corp. is recalling 1,749 bottles of Meloxicam 15 mg tablets because one bottle contained a slightly oversized tablet.

    Product
    Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2146-2012·2012-08-15

    Encore Medical Recalls Mislabelled 6.5 mm Cancellous Bone Screws

    Encore Medical is recalling 18 bone screws because the package label incorrectly states the size is 30mm, while the actual screw dimension is 25mm.

    Product
    djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1925-2012·2012-08-15

    Maya Kaimal Coconut Curry Simmer Sauce Recalled for Bloated Containers

    Two Chefs On A Roll, Inc. is recalling Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce due to bloated containers. The product was distributed to accounts in eight northeastern states.

    Product
    Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub)
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1445-2012·2012-08-15

    Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Testing Failures

    Oklahoma Respiratory Care Inc is recalling 861 cylinders of compressed oxygen due to missing identity and purity testing and documentation gaps.

    Product
    OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2154-2012·2012-08-15

    Greiner Bio-One Recalls Coagulation Blood Collection Tubes Due to Concentration Error

    Greiner Bio-One is recalling specific lots of 3mL coagulation blood collection tubes because a lower citrate concentration may cause falsely low test results.

    Product
    3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateCPSC·12246·2012-08-14

    Canon Recalls EOS Rebel T4i Cameras Due to Allergic Reaction Risk

    Canon is recalling EOS Rebel T4i digital cameras because a chemical in the rubber grips can cause skin irritation. Consumers should stop using the cameras and contact Canon for free replacement grips.

    Product
    EOS Rebel T4i Digital SLR Cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide