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.

10976–11000 of 21617

  • ModerateFDA (Devices)·Z-1047-2018·2018-03-21

    Zimmer Biomet Recalls CR-FLEX 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 OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT FEM F-L CR-FLEX OPT FEM F-R CR-FLEX OPT FEM G-L CR-FLEX OPT FEM G-R This device is indicated for patients with severe knee pain and disa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

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

    Product
    VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    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-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-1036-2018·2018-03-21

    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 FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2018·2018-03-21

    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 PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR-FLEX PCT FEM F-L MINUS CR-FLEX PCT FEM F-R MINUS CR-FLEX PCT FEM G-L MINUS CR-FLEX PCT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2018·2018-03-21

    Diagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect

    Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that may cause inaccurate prothrombin time test results.

    Product
    STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
    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-0933-2018·2018-03-21

    Vygon IV Start Convenience Kits Recalled for Iodine Stability Issues

    Vygon MFG, Inc. is recalling IV Start Convenience Kits because the iodine prep pads failed stability testing for their expiration date.

    Product
    Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.
    Category
    Medical Device
    Distribution
    0 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-1027-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

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

    Product
    VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    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-1018-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

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

    Product
    CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1053-2018·2018-03-21

    Zimmer Biomet Recalls Patella Femoral Joint Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 patella femoral joint implants because LDPE bag packaging may leave residue on the polished surface.

    Product
    ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0939-2018·2018-03-21

    Zimmer Biomet Recalls Mislabeled Trabecular Metal Primary Hip Prostheses

    Zimmer Biomet is recalling 24 units of Trabecular Metal Primary Hip Prostheses due to mislabeling. The affected devices were distributed in the US and several international countries.

    Product
    Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1048-2018·2018-03-21

    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 POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

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

    Product
    VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide