The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) 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 device 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.

201–225 of 450

  • HighFDA (Devices)·Z-2401-2021·2021-09-08

    Smiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device

    Smiths Medical ASD Inc. is recalling 1,590 units of Smiths Medical Portex Tracheal Intubation Stylets because incorrect devices were found in packages. The affected lot was distributed internationally.

    Product
    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2331-2021·2021-09-01

    FDA Recalls AltiVate Shoulder Implant System Due to Component Mating Failure

    The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.

    Product
    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2170-2021·2021-08-11

    Stryker Nail Insertion Sleeve Recalled for Incorrect Inner Diameter

    Stryker is recalling Nail Insertion Sleeves with incorrect inner diameters that do not match the box label. The dimensional mismatch could affect proper fit during orthopedic surgical procedures.

    Product
    Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2136-2021·2021-08-04

    Medtronic Endurant IIs stent graft system marker detachment recall

    Medtronic is recalling 21 Endurant IIs stent graft systems due to radiopaque marker bond detachment during device deployment. The defect could affect surgical visualization and device positioning.

    Product
    Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1991-2021·2021-07-07

    PowerPICC Catheter Kits Recalled for Incorrect Micro-Introducer Components

    Bard Access Systems is recalling 180 units of 5Fr PowerPICC Catheter kits because they contain incorrect micro-introducers.

    Product
    5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use: PowerPicc Polyurethand Radiology PiCC with Microintroducer
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1949-2021·2021-06-30

    FDA Recalls Medical Action Minor Procedure Trays for Flaking Metal on Hemostats

    Medical Action Industries is recalling 31 cases of Minor Procedure Trays because hemostats in the kits may have flaking metal or brown spots that could compromise sterile surgical procedures.

    Product
    Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recalled for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters due to defects in the distal connector that may prevent proper catheter passage or locking.

    Product
    REF 7617408, Groshong NXT ClearVue Catheter, Full Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035255 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2021·2021-05-26

    Bard Groshong Catheter Recall for Connector Defects

    Bard Access Systems is recalling specific lots of Groshong NXT ClearVue Catheters due to connector defects that may prevent proper catheter passage or locking.

    Product
    REF 7617408D, Groshong NXT ClearVue Catheter, Maximal Barrier Kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741035262 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2021·2021-05-26

    Bard Groshong NXT ClearVue Catheter Recall for Connector Defects

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters because connector defects may prevent proper catheter passage or locking.

    Product
    REF 7617405J, Groshong NXT ClearVue Catheter, Basic kit, 4F, Single-Lumen, 60 cm, UDI: (01)10801741200592 - Product Usage: is designed for use when central venous catheterization is prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2021·2021-04-14

    Arrow OnControl Bone Lesion Biopsy System Recalled for Insertion Defect

    Arrow International is recalling OnControl Bone Lesion Biopsy Systems because the ejector rod may not insert properly, preventing sample collection.

    Product
    Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1345-2021·2021-04-14

    Fenwal Recalls Amicus Exchange Kits Due to Centrifuge Pack Leaks

    Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.

    Product
    Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2021·2021-03-10

    ACIST Kodama Intravascular Ultrasound Catheter Recalled for Damaged O-Ring

    Acist Medical Systems is recalling Kodama Intravascular Ultrasound Catheters because damaged o-ring fragments could be flushed out of the device.

    Product
    ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultraso
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2021·2021-02-24

    Medtronic Recalls Cerebrospinal Fluid Valves Due to Radiopaque Marking Issues

    Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid valves and shunts worldwide because radiopaque markings may vary in visibility under imaging.

    Product
    Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT 2781
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2021·2021-02-24

    Medtronic CSF-Flow Control Valves Recalled for Radiopaque Marking Visibility Issues

    Medtronic Neurosurgery is recalling 20,817 CSF-Flow Control Valves worldwide due to potential variation in radiopaque marking visibility under radiographic imaging.

    Product
    Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW 22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L 22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED 22017 B-L - SHUNT 22017 B-L ASSY US PE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2021·2020-12-30

    Boston Scientific Recalls IceFORCE Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 75 units of IceFORCE 2.1 CX Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceFORCE" 2.1 CX Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2021·2020-12-16

    Medtronic Evolut PRO System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling 71,030 Evolut PRO System units worldwide due to a potential for transcatheter aortic valve leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2021·2020-12-16

    Medtronic Evolut R System Recalled for Potential Valve Leaflet Damage

    Medtronic is recalling Evolut R System transcatheter aortic valves due to a potential risk of leaflet damage during post-implant balloon dilatation.

    Product
    Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level III

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 342 vials of MassChrom Amino Acid Analysis Plasma Control Level III due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2021·2020-12-16

    Chromsystems Recalls MassChrom Amino Acid Analysis Plasma Control Level II

    Chromsystems Instruments & Chemicals GmbH is voluntarily recalling 363 vials of MassChrom Amino Acid Analysis Plasma Control Level II due to a Class II device defect.

    Product
    MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0181-2021·2020-10-28

    Boston Scientific Recalls Opticross 35 Peripheral Imaging Catheters

    Boston Scientific is recalling 41 Opticross 35 Peripheral Imaging Catheters because length markings may flake off during manipulation. No patient harm has been reported.

    Product
    Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700 Product Usage: intended for ultrasound examination of p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2969-2020·2020-09-23

    Avanos MIC-KEY SF Gastrostomy Feeding Tube Recalled for Cracks

    Avanos Medical is recalling 284 units of MIC-KEY SF Gastrostomy Feeding Tubes because the devices had cracked or detached from the feeding tube body.

    Product
    AVANOS MIC-KEY SF Gastrostomy Feeding Tube
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2658-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled for Internal Valve Leakage

    Carefusion 2200 Inc is recalling Safe-T 5 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states