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.

11001–11025 of 21617

  • ModerateFDA (Devices)·Z-1060-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Natural-Knee Flex System femoral components because LDPE packaging may leave residue on the polished implant surface.

    Product
    GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 RT Components with CSTi porous coating are indicated for uncemented or cemented use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1058-2018·2018-03-21

    Zimmer Biomet Recalls Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 CR-FLEX knee implants because LDPE packaging may leave residue on the polished surface.

    Product
    CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF PCT SZ E-R MINUS¿¿ CR-FLEX GSF PCT SZ F-L MINUS¿ CR-FLEX GSF PCT SZ F-R MINUS¿ CR-FLEX GSF PCT SZ G-L MINUS¿ CR-FLEX GSF PCT SZ G-R MINUS¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2018·2018-03-21

    Zimmer Biomet Recalls Versus Hip Stems Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versus hip stems because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0591-2018·2018-03-21

    Oxytocin USP Powder Recalled Due to Insufficient Stability Data

    American Pharmaceutical Ingredients LLC is recalling Oxytocin USP powder because stability data does not support the listed expiration dates.

    Product
    Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2018·2018-03-21

    Arrow CVC Kit Recall for Missing Lot and UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0974-2018·2018-03-21

    Stryker Recalls Collagen Meniscus Implants Due to Temperature Packaging Defect

    Stryker is recalling 155 Collagen Meniscus Implants shipped to the Netherlands without required temperature control packaging, potentially exposing them to elevated temperatures.

    Product
    CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based meniscus implant Product Usage: The CMI device, Ivy Sports Medicine s collagen-based meniscus implant, is comprised primarily of bovine type I collagen (nominally 99%) derived from tendon and small q
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1068-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Reagent Due to Homogeneity Defect

    Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1021-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 10 INCH BEADED FC REV 15.0X250MM BWD LT & RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1022-2018·2018-03-21

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Residue

    Zimmer Biomet is recalling Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1062-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.

    Product
    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1055-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surfaces.

    Product
    FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2018·2018-03-21

    Valganciclovir Tablets Recalled Due to Temperature Exposure During Shipping

    Hetero Labs Limited is recalling Valganciclovir Tablets 450 mg because they were exposed to high temperatures during shipping. The recall covers 1,764 bottles distributed nationwide.

    Product
    VALGANCICLOVIR — VALGANCICLOVIR (VALGANCICLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1043-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0592-2018·2018-03-21

    American Pharmaceutical Ingredients Recalls Sermorelin Acetate Powder Due to Stability Data

    American Pharmaceutical Ingredients LLC is recalling Sermorelin Acetate powder because stability data does not support the listed expiration dates.

    Product
    Sermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18V176000·2018-03-15

    Toyota Recalls 2018 Prius C Vehicles for Missing Air Bag Labels

    Toyota is recalling 2018 Prius C vehicles sold in Puerto Rico because the front passenger air bag and child seating labels may be missing, increasing crash injury risk.

    Product
    TOYOTA — TOYOTA PRIUS C
    Category
    Vehicle
    Distribution
    Distributed nationwide