The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

42001–42025 of 50511

  • HighFDA (Drugs)·D-465-2014·2014-01-22

    Aidapak Recalls Omega-3 Fatty Acid Capsules Due to Labeling Error

    Aidapak Services, LLC is recalling 2,799 Omega-3 Fatty Acid capsules because they may be mislabeled as Docusate Calcium. The error could lead to patients receiving the wrong medication.

    Product
    OMEGA-3 FATTY ACID, Capsule, 1000 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904404360
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-731-2014·2014-01-22

    FDA Recalls Pramipexole Tablets Due to Potential Labeling Error

    Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets that may be mislabeled as Liothyronine Sodium. The error poses a risk of incorrect medication administration.

    Product
    PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0742-2014·2014-01-22

    Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-408-2014·2014-01-22

    Lupin Recalls Quinapril Tablets Due to Unknown Impurity

    Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-639-2014·2014-01-22

    Aripiprazole Tablets Recalled for Potential Labeling Mixup

    Aidapak Services is recalling Aripiprazole 2 mg tablets because they may be mislabeled as other prescription drugs.

    Product
    ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-527-2014·2014-01-22

    Leflunomide Tablets Recalled Due to Potential Labeling Mixup

    Aidapak Services is recalling Leflunomide 10 mg tablets because they may be mislabeled as Doxycycline or Sevelamer Carbonate.

    Product
    LEFLUNOMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155004303
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-691-2014·2014-01-22

    Zolpidem Tartrate Tablets Recalled for Potential Labeling Error

    Aidapak Services is recalling Zolpidem Tartrate tablets that may be mislabeled as Temazepam capsules due to a label mixup.

    Product
    ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0747-2014·2014-01-22

    GE Healthcare Carescape Patient Data Module Recall for Latch Failure

    GE Healthcare is recalling Carescape Patient Data Modules due to a potential safety issue involving the intermittent failure of the spring-loaded mounting latch.

    Product
    GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-557-2014·2014-01-22

    Liothyronine Sodium Tablets Recalled for Potential Labeling Errors

    Aidapak Services is recalling Liothyronine Sodium 25 mcg tablets because they may be mislabeled as Guanfacine or Bromocriptine.

    Product
    LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001902
    Category
    Drug
    Distribution
    4 states
  • HighCPSC·14084·2014-01-22

    Playtex Recalls Pacifier Holder Clips Due to Choking Hazard

    Playtex is recalling pacifier holder clips because they can crack and break off small parts, posing a choking hazard to small children.

    Product
    Playtex pacifier holder clips
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-491-2014·2014-01-22

    Aidapak Recalls Docusate Sodium Capsules Due to Potential Label Mixup

    Aidapak Services, LLC is recalling 4,318 Docusate Sodium capsules because they may be mislabeled as other medications. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

    Product
    DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Food)·F-1394-2014·2014-01-22

    Jensen's Recalls Hot Smoked Pink Salmon for Botulism Risk

    Jensen's Old Fashioned Smokehouse is recalling 20,271 lbs of Hot Smoked Pink Salmon in Washington due to missing 'KEEP FROZEN' labels and potential Clostridium botulinum contamination.

    Product
    Hot Smoked Pink Salmon is Low salt, vacuum packaged. Clippership Hot Smoked Pink Salmon does not have any labels. Lummi Island Co-Op product's label is read in parts: "***WILD SMOKED PINK SALMON***LUMMI ISLANDWILD.COM***KEEP FROZEN***Thawing Instructions: Remove all…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0733-2014·2014-01-22

    Vital Diagnostics Recalls Eon Calcium Reagent Due to High Positive Bias

    Vital Diagnostics, Inc. is recalling 213 units of Eon Calcium Reagent because high positive calcium bias was observed in plasma samples compared to serum results.

    Product
    Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2014·2014-01-22

    Boston Scientific Recalls Extractor Pro XL Retrieval Balloon Catheters

    Boston Scientific is recalling 39 units of Extractor Pro XL Retrieval Balloon Catheters due to potential incorrect skive hole location or balloon size.

    Product
    Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-412-2014·2014-01-22

    FDA Recalls Bevacizumab Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.

    Product
    Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0720-2014·2014-01-22

    Boston Scientific Recalls TWISTER PLUS Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 425 TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in flexible endoscopes as a retrieval device for foreign…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2014·2014-01-22

    Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk

    Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.

    Product
    Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2014·2014-01-22

    Boston Scientific Recalls Twister Plus Retrieval Devices Due to Seal Integrity Issues

    Boston Scientific is recalling 253 Twister Plus 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.

    Product
    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2014·2014-01-22

    Anspach Carbide Cutting Burrs Recalled Due to Fracture During Use

    The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The recall covers 28,562 units distributed worldwide.

    Product
    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1386-2014·2014-01-22

    Colony Brands Recalls Lobster Bisque Due to Undeclared Wheat Allergen

    Colony Brands is recalling 19 units of Lobster Bisque because the product contains undeclared wheat. The recall affects specific lots distributed across 12 states.

    Product
    Lobster Bisque, product 45036. Net WT 4.0 lbs. Keep Frozen.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0772-2014·2014-01-22

    Becton Dickinson Recalls BD Interlink Threaded Lock Cannula Due to Seal Defects

    Becton Dickinson is recalling BD Interlink Threaded Lock Cannulas because some units may have open seals, compromising sterility.

    Product
    BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling 1,002 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems due to potential tubing leaks or disconnections.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock; .Product Code: 2052-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-645-2014·2014-01-22

    Aidapak Recalls Mirtazapine Tablets Due to Potential Labeling Mixup

    Aidapak Services, LLC is recalling Mirtazapine 7.5 mg tablets because they may be mislabeled as other prescription medications.

    Product
    MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Devices)·Z-0735-2014·2014-01-22

    Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recall

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.

    Product
    Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2014·2014-01-22

    Teleflex Recalls Electrosurgical Coagulation Suction Tubes Due to Sterility Concerns

    Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices are distributed nationwide.

    Product
    Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.
    Category
    Medical Device
    Distribution
    Distributed nationwide