The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

1576–1600 of 2769

  • LowFDA (Devices)·Z-2580-2016·2016-08-24

    Ortho-Clinical Diagnostics Recalls VITROS TSH Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK For the in vitro quantitative measurement of thyroid stimulating hormone (TSH
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2446-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

    Biomet 3i, LLC is recalling Standard Abutment Transfer Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Standard Abutment Transfer Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2438-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling Prep-tite Cap Dental implants because pouches may not have been sealed during packing.

    Product
    Prep-tite Cap Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2511-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i is recalling EP Twist Lock Coping Dental implants because pouches may not have been sealed during packing.

    Product
    Certain EP Twist Lock TM Coping Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2512-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants because pouches may not have been sealed during packing.

    Product
    Certain Bellatek Encode Healing Abutment Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2414-2016·2016-08-24

    Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

    Biomet 3i, LLC is recalling certain Pick-Up Coping dental implants because pouches may not have been sealed during packing.

    Product
    Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2378-2016·2016-08-17

    BD Tritest CD3/CD4/CD45 Reagent Recalled for Incorrect Labeling

    Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.

    Product
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll protei
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2342-2016·2016-08-17

    BioMerieux Recalls NucliSENS easyMAG Magnetic Silica Reagents

    BioMerieux is recalling NucliSENS easyMAG Magnetic Silica reagents due to customer complaints about amplification performance issues.

    Product
    NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2345-2016·2016-08-17

    Medivance ArcticGel Neonatal Pad Recalled for Missing Multilingual Instructions

    C.R. Bard is recalling 64 Medivance ArcticGel Neonatal Pads because the included instructions were missing required languages for CE-marked products.

    Product
    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
    Category
    Medical Device
    Distribution
    13 states
  • LowFDA (Devices)·Z-2333-2016·2016-08-10

    C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

    C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

    Product
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2311-2016·2016-08-10

    Branan Medical Recalls AmediCheck Instant Test Cups Due to Packaging Error

    Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.

    Product
    AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2327-2016·2016-08-10

    Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels

    Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.

    Product
    Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip is
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Drugs)·D-1453-2016·2016-08-10

    Teva Recalls Children's Qnasl Nasal Aerosol for Content Uniformity Failure

    Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.

    Product
    Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324;
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2271-2016·2016-08-03

    Alere Signify Mono Test Recalled for Incorrect Labeling Information

    Alere San Diego is recalling Signify Mono tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2267-2016·2016-08-03

    Alere Clearview MONO Test Recalled for Incorrect Labeling

    Alere San Diego is recalling Clearview MONO tests because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2265-2016·2016-08-03

    Alere Acceava Mono II Rapid Test Strip Labeling Recall

    Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2269-2016·2016-08-03

    Alere Proadvantage Mono Rapid Test Cassette Recalled for Labeling Error

    Alere San Diego, Inc. is recalling Proadvantage Mono Rapid Test Cassettes because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2268-2016·2016-08-03

    Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error

    Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2282-2016·2016-08-03

    Tosoh Bioscience Recalls Progesterone 3 Calibrator Sets Due to Incorrect IFU Lot Number

    Tosoh Bioscience is recalling 41 sets of Progesterone 3 Calibrators because the included Instructions for Use (IFU) listed the incorrect lot number.

    Product
    Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. The Instructions for Use (IFU) included in the package was for the incorrect lot number. Only the IFU required correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2270-2016·2016-08-03

    Alere San Diego Recalls Stanbio Rely Mono Rapid Test for Labeling Error

    Alere San Diego is recalling the Stanbio Rely Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1451-2016·2016-08-03

    Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels

    Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2266-2016·2016-08-03

    Alere Mono Rapid Test Recalled for Incorrect Labeling Information

    Alere San Diego, Inc. is recalling the Cardinal Health Mono Rapid Test because the product labeling incorrectly identifies the positive control material as human plasma.

    Product
    Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1446-2016·2016-07-27

    Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failure

    Sun Pharmaceutical Industries is recalling 16,085 bottles of Bupropion Hydrochloride Extended Release Tablets because they failed dissolution specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide