The Recall Desk

Hazard

Functional Defect recalls

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

What the numbers show

Total
293
Critical
0
Severe
2
Most recent
2026-08-26

Of the 293 functional defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (1%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional defect 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.

51–75 of 293

  • HighFDA (Devices)·Z-1373-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1366-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1169-2020·2020-02-19

    DePuy Orthopaedics Recalls Specialist 2 Distal Femoral Cutting Blocks

    DePuy Orthopaedics is recalling 140 Specialist 2 Distal Femoral Cutting Blocks because they will not connect to the required outrigger, rendering them unusable in surgery.

    Product
    SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1105-2020·2020-02-12

    Intuitive Surgical Recalls Da Vinci Xi EndoWrist Monopolar Curved Scissors

    Intuitive Surgical is recalling 286 Da Vinci Xi EndoWrist Monopolar Curved Scissors because they are not recognized by the integrated electrosurgical unit, preventing the activation of monopolar energy.

    Product
    Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0871-2020·2020-02-05

    Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure

    Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts because the shaft end may fail to mate effectively with the broach.

    Product
    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2020·2020-01-29

    Paltop Dental Implant Recall Due to Incorrect Cover Screw Packaging

    Paltop Advanced Dental Solutions is recalling 67 dental implants because some were packaged with the wrong cover screw, preventing proper fit.

    Product
    Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0818-2020·2020-01-29

    Greiner Bio-One Recalls Damaged Vacuette Blood Collection Tubes

    Greiner Bio-One is recalling 1,002,000 Vacuette tubes that may have cap sealing damage, potentially causing vacuum loss and improper blood volume collection.

    Product
    VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0828-2020·2020-01-29

    Medicrea Pass LP Blunt K-wire Recalled for Incompatibility with Screws

    Medicrea International is recalling 190 units of Pass LP Blunt K-wires because they may not fit into Conical Cannulated Screws.

    Product
    Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2020·2020-01-15

    Medacta Shoulder Implant Recall Due to Screw Insertion Limitation

    Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.

    Product
    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2020·2020-01-08

    Deerfield iMRX MRI and Angiography System Recalled for Hardware Error

    Deerfield Imaging is recalling six iMRX MRI and Angiography Systems due to a potential hardware error in the generator A100 power supply that may prevent X-ray operation.

    Product
    iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRI
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0342-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 25,840 Grab n Go Opti VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0339-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 1,287 Grab n Go Opti VIPR oxygen delivery systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 486 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0340-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 143,164 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0242-2020·2019-11-06

    Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0261-2020·2019-11-06

    Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly

    Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.

    Product
    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0189-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

    Product
    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2019·2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The Accu
    Category
    Medical Device
    Distribution
    Distributed nationwide