The Recall Desk

Hazard

Device Mismatch recalls

18 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
18
Critical
0
Severe
1
Most recent
2025-04-02

Of the 18 device mismatch recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device mismatch recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–18 of 18

  • ModerateFDA (Devices)·Z-1434-2025·2025-04-02

    Prelude IDEAL 4F Hydrophilic Sheath Introducer contains incorrect 5F dilators

    Merit Medical Systems is recalling Prelude IDEAL 4F Hydrophilic Sheath Introducer units (Lot H3082668) that contain 5F dilators instead of the labeled 4F dilators, which may result in procedure delay.

    Product
    Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0981-2025·2025-01-29

    Stryker neurosurgical device labeling mismatch: wrong instruments shipped

    Stryker is recalling 3.0MM Neuro Match Head devices (REF 5820-107-430) where the actual device may not match the product label, potentially causing surgeons to use wrong instruments during neurosurgery.

    Product
    stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2024·2023-12-13

    DJO EMPOWR Knee System Recall: Incorrect Device in Packaging

    Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.

    Product
    DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1851-2021·2021-06-23

    Hip prosthesis components recalled for mislabeling with incorrect sizes and types

    Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.

    Product
    Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2042-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.

    Product
    00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Steri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2013·2013-08-28

    Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

    Zimmer is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE G
    Category
    Medical Device
    Distribution
    Distributed nationwide