The Recall Desk

State

Massachusetts product recalls

20,364 recalls have nationwide distribution and so reach Massachusetts. 0 additional recalls listed Massachusetts specifically in their distribution scope.

About recalls in Massachusetts

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Massachusetts consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

14701–14725 of 20364

  • HighFDA (Devices)·Z-0794-2023·2023-01-11

    FDA Recalls Reagent Nozzle Cleaning Solution Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling a reagent nozzle cleaning solution (Catalog 29588) because storage temperature and time conditions were exceeded, preventing product performance guarantee.

    Product
    PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2023·2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2023·2023-01-11

    Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation

    Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2023·2023-01-11

    ETEST Clinical Erythromycin test plates recalled for storage temperature deviation

    Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.

    Product
    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2023·2023-01-11

    ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.

    Product
    ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2023·2023-01-11

    TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion

    Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.

    Product
    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2023·2023-01-11

    VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2023·2023-01-11

    VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure

    Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.

    Product
    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2023·2023-01-11

    Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

    Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.

    Product
    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2023·2023-01-11

    Epi-Caine Intraocular Injection Recalled Due to Raw Material Discoloration

    Pine Pharmaceuticals is recalling Epi-Caine intraocular injection (11,453 vials nationwide) due to discoloration in raw material used for compounding, a manufacturing quality control failure.

    Product
    Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2023·2023-01-11

    FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.

    Product
    VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2023·2023-01-11

    Biomerieux VIDAS Progesterone Tests Recalled for Storage Condition Failure

    Biomerieux is recalling VIDAS Progesterone 60 diagnostic tests (Batch 1009375960) nationwide due to storage temperature and time conditions being exceeded, preventing guaranteed product performance.

    Product
    VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2023·2023-01-11

    VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure

    Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.

    Product
    VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2023·2023-01-11

    Steris VERIFY Steam Test Pack biological indicators show inconsistent performance

    Steris Corporation is recalling VERIFY Steam Test Pack biological indicators (lot #230613) due to inconsistent performance in promoting spore growth. When used to monitor sterilization, some indicators may not show growth even if the sterilization cycle was ineffective, creating false assurance of sterility.

    Product
    VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2023·2023-01-11

    FDA Recalls Antibiotic Susceptibility Test Strips Due to Storage Condition Excursion

    Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations

    Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.

    Product
    VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2023·2023-01-11

    Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise

    Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.

    Product
    Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2023·2023-01-11

    PPM Lombard Phosphate Buffer Recall Due to Temperature Exposure

    Biomerieux Inc is recalling PPM Lombard Phosphate Buffer products due to temperature and time exposure during storage or transport that may have compromised product performance.

    Product
    PPM LOMBARD PRODUCTS T PHOSPHATE BUFFERSTERILE 20X9ML, CATALOG T8035
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2023·2023-01-11

    Detect COVID-19 Test may produce false negative results in affected lots

    Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.

    Product
    Detect Covid-19 Test Product/Model Number: 21205
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2023·2023-01-11

    VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure

    Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.

    Product
    VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
    Category
    Medical Device
    Distribution
    Distributed nationwide