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.

17851–17875 of 21645

  • ModerateFDA (Devices)·Z-2655-2014·2014-09-24

    B. Braun AccuFlo Elastomeric Infusion Device Labeling Recall

    B. Braun Medical is recalling AccuFlo infusion devices in Missouri due to a mismatch between inner and outer packaging labels.

    Product
    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2638-2014·2014-09-24

    Amerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2662-2014·2014-09-24

    Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading

    Siemens is correcting ADVIA Centaur systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2452-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Backyard Mint Straciatella Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Backyard Mint Straciatella frozen dessert because the product labeling does not include ingredients.

    Product
    Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2661-2014·2014-09-24

    Teleflex Recalls Soft Rubber Bladder Catheters Due to Missing Latex Warning

    Teleflex Medical is recalling sterile soft rubber bladder catheters because the product labels failed to include a Natural Rubber Latex caution statement.

    Product
    Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2646-2014·2014-09-24

    Advanced Photonic Systems Recalls Luxurian Devices for Marketing Violations

    Advanced Photonic Systems is recalling 235 Luxurian devices because they were marketed without FDA clearance or approval.

    Product
    Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims…
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Food)·F-2464-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Goat Cheese Fig Cognac Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling goat cheese with Fig Cognac frozen dessert because the product labeling does not list ingredients.

    Product
    Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2651-2014·2014-09-24

    Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts

    Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.

    Product
    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2481-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Winter Squash Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Winter Squash frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2633-2014·2014-09-24

    Fresenius Medical Care Recalls BD Vacutainer Citrate Tubes Due to Storage Issues

    Fresenius Medical Care is recalling BD Vacutainer Citrate Tubes because they were held at improper storage temperatures. The affected tubes were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-2454-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Bourbon Egg Nog Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Bourbon Egg Nog frozen dessert because the product labeling does not include ingredients.

    Product
    Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2453-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Berries and Burgundy frozen desserts because the packaging does not list ingredients.

    Product
    Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2623-2014·2014-09-17

    Medtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation

    Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.

    Product
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2613-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2014·2014-09-17

    Integra Container Lids Recalled for Lack of FDA Clearance

    Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.

    Product
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2602-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Material Error

    Wright Medical Technology is recalling 1,127 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2014·2014-09-17

    BD MAX MRSA Assay Recalled for False Positive Results

    Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.

    Product
    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2596-2014·2014-09-17

    Primus Medical Recalls Transcend and Bariatric Mattresses Due to Delamination

    Primus Medical LLC is recalling specific Transcend and Bariatric mattresses because the top cover is delaminating. The recall affects 1,557 units distributed in the US and Canada.

    Product
    Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2598-2014·2014-09-17

    Merci Retriever Medical Devices Recalled for Expiration Date Issues

    Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.

    Product
    Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2570-2014·2014-09-17

    CooperSurgical H/S Catheter Recalled Due to Unsealed Pouches

    CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.

    Product
    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2595-2014·2014-09-17

    Catheter Connections Recalls DualCap IV Pole Strips Due to Packaging Seal Defect

    Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.

    Product
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2573-2014·2014-09-10

    Pioneer Surgical Technology Recalls Streamline CT Set Screws

    Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.

    Product
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2566-2014·2014-09-10

    Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up

    Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.

    Product
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2591-2014·2014-09-10

    Mentor Saline Breast Implant Sizer Recalled for Volume Labeling Error

    Mentor Texas, LP. is recalling 34 units of saline breast implant sizers because the device labeling states 330cc while the actual device volume is 380cc.

    Product
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide