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.

12401–12425 of 21617

  • ModerateFDA (Devices)·Z-2462-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-GP74), REF 414971, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2558-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Femoral Intramedullary Nail Implants

    Zimmer Biomet is recalling sterile femoral intramedullary nail implants due to packaging design verification test failures.

    Product
    Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2504-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2344-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Bacillus Identification Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Bacillus identification cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK 2 Bacillus identification card (BCL), IVD, REF 21345, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2352-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised containers may allow moisture to degrade antibiotic potency.

    Product
    VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0903-2017·2017-06-21

    Safecor Recalls Acyclovir 400mg Tablets Due to Manufacturing Deviations

    Safecor Health is recalling 601 bottles of Acyclovir 400mg tablets distributed in Massachusetts and New York due to CGMP deviations.

    Product
    Acyclovir 400mg Tablet, 15-count bottles, Rx only, Packaged by Safecor Health, LLC. Woburn, MA 01801, NDC 0093894305
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2440-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 413865, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2574-2017·2017-06-21

    Zimmer Biomet Recalls Segmental Fluted Stems Due to Packaging Failures

    Zimmer Biomet is recalling sterile segmental fluted stems because packaging design verification tests failed. The recall covers 9,867 units distributed worldwide.

    Product
    Segmental fluted stem, 18x250mm bwd, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2372-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Streptococcus Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Streptococcus Susceptibility cards because container integrity issues may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01), REF 410028, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2017·2017-06-21

    Arrow Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.

    Product
    1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2473-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling 493 cartons of VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD, REF 416241, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2519-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling 474 cartons of VITEK 2 Gram Negative Susceptibility cards because container integrity issues may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2478-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2541-2017·2017-06-21

    Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2434-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised container integrity may expose the product to moisture, potentially causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N253), REF 413722, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2550-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures

    Zimmer Biomet is recalling sterile intramedullary nail implants because packaging design verification tests failed. The recall covers 9,867 units distributed worldwide.

    Product
    Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2381-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Moisture Risk

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because compromised container integrity may expose the product to moisture, potentially degrading antibiotic potency.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P621), REF 412533, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0898-2017·2017-06-21

    Hospira Recalls Levophed Injection Due to Foreign Stopper Observation

    Hospira is recalling specific lots of Levophed (norepinephrine bitartrate) injection after a foreign stopper was observed during packaging.

    Product
    LEVOPHED — LEVOPHED (NOREPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2467-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because compromised containers may expose the product to moisture, leading to antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N292), REF 415063, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2562-2017·2017-06-21

    Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures

    Zimmer Biomet is recalling sterile femoral intramedullary nails because packaging design verification tests failed. The action affects specific lots distributed worldwide.

    Product
    Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2466-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Positive Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Positive Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Positive Susceptibility card (AST-P632), REF 415059, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2450-2017·2017-06-21

    Biomerieux Recalls VITEK 2 Gram Negative Susceptibility Cards

    Biomerieux Inc is recalling VITEK 2 Gram Negative Susceptibility cards because container integrity may be compromised, potentially exposing the product to moisture and causing antibiotic degradation.

    Product
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per carton.
    Category
    Medical Device
    Distribution
    Distributed nationwide