The Recall Desk

Hazard

Incorrect Component recalls

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

What the numbers show

Total
54
Critical
0
Severe
0
Most recent
2026-08-19

Of the 54 incorrect component recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 incorrect component 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.

1–25 of 54

  • HighFDA (Devices)·Z-2934-2026·2026-08-19

    Waldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets

    Waldemar Link is recalling Endo-Model tibial plateau replacement sets that incorrectly contain a Pure Hinge plateau, posing a risk of increased wear if implanted.

    Product
    Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2524-2026·2026-07-01

    TMJ Bilateral Implants with Incorrect Patient-Specific Components Recalled

    TMJ Solutions Inc is recalling TMJ Bilateral Implants (REF: CHG020) because some units may contain incorrect patient-specific components, causing poor implant fit and right-sided open bite.

    Product
    TMJ Bilateral Implants, REF: CHG020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2024·2024-08-28

    Disposable 5 Lead Cable System May Contain Non-Approved ECG Leads

    Stryker Sustainability Solutions is recalling disposable 5 lead cable systems that may contain non-approved ECG leads which were improperly reprocessed. The wrong components may cause devices to malfunction.

    Product
    Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2024·2023-10-18

    Reverse Shoulder Prosthesis Screws May Have Incorrect Size

    Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.

    Product
    REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1638-2022·2022-09-07

    Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion

    Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.

    Product
    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2243-2021·2021-08-18

    Merit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator

    Merit Medical is recalling 373 Prelude Short Sheath Introducer units from lot H2069291 due to potential incorrect dilators in some packages. The defect could affect device functionality in clinical procedures.

    Product
    MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2021·2020-10-14

    Bard Conquest PTA Balloon Catheter Recalled for Incorrect Balloon Size

    Bard Peripheral Vascular Inc is recalling 281 units of the Conquest PTA Balloon Dilation Catheter because some units contain a 5mm balloon instead of the labeled 6mm size.

    Product
    Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI: (01) 00801741062902 - Product Usage: use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2684-2020·2020-07-29

    Nuvasive NVM5 EMG Module Recalled for Incorrect Component

    NuVasive Inc is recalling 23 NVM5 EMG Modules because they contain an incorrect SSEP harness instead of the correct NVM5 Harness, potentially delaying spinal surgery monitoring.

    Product
    Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2642-2020·2020-07-29

    LivaNova Recalls Sterile Disposable Connectors Due to Incorrect Reducer Parts

    LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.

    Product
    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2209-2020·2020-06-10

    Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath

    Bard Peripheral Vascular Inc is recalling 400 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.

    Product
    EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2208-2020·2020-06-10

    Bard Equistream XK Hemodialysis Catheter Recalled for Incorrect Sheath

    Bard Peripheral Vascular Inc is recalling 215 Equistream XK Long-Term Hemodialysis Catheters because the kits contain an incorrect peel-apart introducer sheath.

    Product
    EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913230/:(01)00801741013843; 16F
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1914-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 350 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-1575-2020·2020-04-01

    BardPort Titanium Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.

    Product
    BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2020·2020-04-01

    Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2020·2020-04-01

    Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0363-2020·2019-11-20

    Implant Direct Dental Implants Recalled for Potential Packaging Error

    Implant Direct is recalling 53 dental implants because an internal quality inspection found that an incorrect healing collar could have been packaged in the assembly kit.

    Product
    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0670-2019·2019-01-02

    In2bones Recalls NeoSpan Compression Staple Kits Due to Incorrect Drill Bit Size

    In2bones USA, LLC is recalling NeoSpan SuperElastic Compression Staple kits because they contain a 3mm drill bit instead of the required 2mm bit.

    Product
    NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0076-2019·2018-10-17

    AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly

    AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.

    Product
    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2019·2018-10-10

    Exactech Equinoxe Reverse Drill Bit Kit Recalled for Incorrect Components

    Exactech is recalling Equinoxe Reverse Drill Bit Kits because they may contain two 2mm drill bits instead of the intended 2mm and 3.2mm combination.

    Product
    Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1938-2018·2018-06-06

    Ad-Tech Medical Recalls Disposable Drill Kits Due to Potential Component Mix-Up

    Ad-Tech Medical Instrument Corporation is recalling 30 sterile Disposable Drill Kits because they may contain drill bits from the wrong catalog number.

    Product
    Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1074-2018·2018-03-21

    Smiths Medical Recalls Misassembled Power PORT-A-CATH II Implantable Port Kits

    Smiths Medical ASD Inc. is recalling 1,077 units of Power PORT-A-CATH II kits that may contain incorrect introducer sizes or locking collars.

    Product
    Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); b. VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED (1/EA); c. VEN LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED (1/EA); d. DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO (1/EA);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0778-2018·2018-03-07

    Alcon 25+ TOTALPLUS Vitrectomy Pak Recalled for Incorrect Probe Inclusion

    Alcon is voluntarily recalling 300 units of the 25+ TOTALPLUS Vitrectomy Pak because a 23GA probe may be included instead of the required 25GA probe.

    Product
    Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a core vitrectomy procedure and connects to the CONSTELLATION Vision System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0657-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.

    Product
    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide