The Recall Desk

Archive

January 2022 recalls

428 recalls were announced in January 2022.

What the numbers show

Critical
3
Severe
158
High
169
Moderate
91
Low
7

Of the 428 recalls this month scored against our rubric, 1% are Critical, 37% are Severe.

401–428 of 428

  • HighFDA (Devices)·Z-0420-2022·2022-01-05

    Ultimum Hemostasis Introducer devices recalled due to manufacturing error

    Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.

    Product
    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2022·2022-01-05

    VIDAS Clostridium Difficile GDH test substrate error causes test failure

    bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.

    Product
    VIDAS Clostridium Difficile GDH, REF 30125-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2022·2022-01-05

    VIDAS diagnostic test for C. difficile recalled due to substrate defect

    bioMerieux's VIDAS Clostridium difficile diagnostic test is being recalled due to a substrate error that prevents the test from running. Users must re-test samples, potentially delaying diagnosis.

    Product
    VIDAS Clostridium Difficile Toxin A&B, CDAB,REF 30118-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2022·2022-01-05

    Cancer treatment linear accelerator systems recalled for wrong-site dosing risk

    Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.

    Product
    ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. Model Number: 8162815
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0307-2022·2022-01-05

    SterRx Succinylcholine Chloride Injection Recalled for Sterility Assurance

    SterRx is recalling Succinylcholine Chloride Injection 20 mg/mL vials (1,000 mL) distributed nationwide due to lack of assurance of sterility. The 3,540 affected bags may pose a risk to patients receiving this injectable drug.

    Product
    Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-826-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0418-2022·2022-01-05

    Percept PC Implantable Neurostimulator May Become Unresponsive During Cardioversion

    The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.

    Product
    Model B35200 - Percept PC BrainSense Implantable Neurostimulator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0324-2022·2022-01-05

    SterRx Phenylephrine HCl Injection Recalled for Sterility Assurance Failure

    SterRx is recalling phenylephrine HCl injectable solution nationwide due to lack of assurance of sterility. The affected product is a 50 mg per 250 mL injection in 0.9% sodium chloride.

    Product
    PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-901-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0439-2022·2022-01-05

    VIDAS SARS-COV-2 Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling two lots of VIDAS SARS-COV-2 IgG diagnostic tests due to substrate errors that prevent test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS SARS-COV-2 IgG, Ref 423834-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2022·2022-01-05

    VIDAS Measles IgG Test Kit Recalled Due to Substrate Error

    bioMerieux is recalling VIDAS Measles IgG test kits due to a substrate error that prevents the test from running, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS Measles IgG (MSG), REF 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2022·2022-01-05

    FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation

    Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.

    Product
    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0355-2022·2022-01-05

    Giant Eagle Diced Green Peppers Recalled for Listeria Contamination

    Giant Eagle, Inc. is recalling frozen diced green peppers (10 oz., Best By 10/14/2023) distributed to stores in Maryland, Pennsylvania, West Virginia, Ohio, and Indiana because the product tested positive for Listeria monocytogenes.

    Product
    Giant Eagle Diced Green Peppers, 10 oz. 283 g, Frozen bag, 12 packages per case , Best By 10/14/2023 .
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0353-2022·2022-01-05

    Raw Tuna at Meat Counter Recalled for High Histamine Levels

    Sant' Elia Operations is recalling raw tuna sold at meat counters in Wisconsin because samples tested above 50 ppm histamine, which can cause illness if consumed.

    Product
    Tuna, raw sold at meat counter and wrapped in butcher paper at point of purchase.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0354-2022·2022-01-05

    BUBS Naturals Collagen Supplement Recalled for Undeclared Milk

    BUBS Naturals Fountain of Youth Formula collagen supplement is recalled nationwide because it contains undeclared milk from an MCT oil powder ingredient. Consumers with milk allergies or sensitivities should not consume this product.

    Product
    BUBS Naturals Fountain of Youth Formula; Collagen Protein; Support for Hair, Skin & Nails; Biotin, Antioxidant, Vitamin C; Maqui Berry Net Wt. 10.16 oz. (288 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0429-2022·2022-01-05

    VIDAS Mumps IgG diagnostic test kit recalled due to substrate error

    bioMerieux is recalling one lot of VIDAS Mumps IgG diagnostic tests because a substrate error prevents the tests from running, causing delays.

    Product
    VIDAS Mumps IgG (MPG), REF 30218
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2022·2022-01-05

    Speech Generation Device Charging Components Recalled for Fire and Electric Shock Hazard

    Forbes Rehab Services is recalling Monoprice charging cables and iClever charging bricks for ProSlate Speech Generation Devices due to fire and electric shock risks if cables are damaged or charging occurs near moisture.

    Product
    Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speech Generation Devices (including Proslate 13: B398PS130; Proslate 10: B398PS100;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0422-2022·2022-01-05

    Diagnostic device recall: incorrect color in package insert reading table

    Biomerieux is recalling RAPID 20 E diagnostic systems because the package insert contains an incorrect color for interpreting negative CIT test results.

    Product
    RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0424-2022·2022-01-05

    FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error

    bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.

    Product
    VIDAS PRG Progesterone, REF 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0297-2022·2022-01-05

    Betamethasone Dipropionate Lotion recalled for failed stability test

    Teligent Pharma is recalling Betamethasone Dipropionate Lotion USP 0.05% (Augmented) due to failure to meet specification for the Active Pharmaceutical Ingredient particle test during routine stability testing.

    Product
    Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0432-2022·2022-01-05

    VIDAS RUB IgG Diagnostic Test Kit Recalled for Substrate Defect

    bioMerieux is recalling three lots of VIDAS RUB IgG test kits due to substrate errors that prevent the test from running, potentially delaying diagnostic results.

    Product
    VIDAS RUB IgG (RBG), REF 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0438-2022·2022-01-05

    VIDAS SARS-CoV-2 IgM Diagnostic Test Recalled for Substrate Error

    bioMerieux is recalling one lot of VIDAS SARS-CoV-2 IgM tests nationwide due to a substrate defect that prevents the test from running. The defect causes delayed results as users must repeat testing.

    Product
    VIDAS SARS-COV-2 IgM, Ref 423833-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0431-2022·2022-01-05

    Diagnostic test kit recalled due to substrate error preventing test execution

    A diagnostic test kit manufactured by bioMerieux has been recalled because a substrate error prevents the test from running, which delays test results for patients.

    Product
    VIDAS TOXO IgG Avidity (TXGA), REF 30222-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0433-2022·2022-01-05

    VIDAS LH diagnostic test substrate error causes delayed results

    bioMerieux VIDAS LH test kits (lot 1008848600) are affected by a substrate error that prevents test execution, requiring users to repeat testing and potentially delaying results.

    Product
    VIDAS LH, REF 30406-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0436-2022·2022-01-05

    VIDAS Lyme IgM II Diagnostic Test Kits Recalled for Substrate Error

    bioMerieux is recalling three lots of VIDAS Lyme IgM II diagnostic test kits due to a substrate error that prevents the test from running, requiring users to conduct another test to obtain results.

    Product
    VIDAS Lyme IgM II (LYM), REF 416436
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0427-2022·2022-01-05

    Diagnostic substrate error in medical testing device causes test failures

    bioMerieux is recalling 1,579 VIDAS DEX@ diagnostic devices due to substrate errors that prevent test execution, requiring users to rerun tests and potentially delaying results.

    Product
    VIDAS DEX@, Dimer Exclusion II, REF 30455-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0296-2022·2022-01-05

    Lidocaine Hydrochloride Topical Solution Recalled for Superpotency

    Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to superpotency. The affected lot was distributed nationwide.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·22V002000·2022-01-04

    LGS Industries Recalls 2014-2021 Trailers with Electric Rear Door Winch Defect

    LGS Industries is recalling 2014-2021 trailers because the electric rear door winch cable may break, allowing the door to fall open and increasing injury risk.

    Product
    LGS INDUSTRIES — LGS INDUSTRIES PREMIER RACE, SHADOW, CARGO SPORT, JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V001000·2022-01-01

    Rosenbauer Fire Trucks Recalled for Fuel Tube Cracking and Fire Risk

    Rosenbauer America is recalling 2018-2022 fire trucks because fuel tubes may crack, causing high-pressure leaks that could lead to fire.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER, WARRIOR, COMMERCIAL 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide

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