The Recall Desk

Hazard

Device Integrity recalls

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

What the numbers show

Total
17
Critical
0
Severe
0
Most recent
2026-07-08

Of the 17 device integrity 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 device integrity 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.

1–17 of 17

  • HighFDA (Devices)·Z-2614-2026·2026-07-08

    Mentor Texas LP Recalls Expired Luer Lok Syringes Due to Distribution Error

    Mentor Texas LP is recalling a single lot of expired 10cc Luer Lok syringes distributed to California, Florida, and Pennsylvania due to a distribution system control failure.

    Product
    SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3259-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug units expire before labeled date

    Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2024·2023-12-27

    Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure

    Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.

    Product
    Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0583-2024·2023-12-27

    Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure

    Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.

    Product
    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0112-2023·2022-10-26

    Medicina Reusable Oral Syringe Recalled for Unapproved Plunger Material

    Medicina Uk Ltd is recalling Medicina Reusable Oral syringes because the plunger was manufactured with polyethylene instead of the required polypropylene material. The 11,100 affected syringes do not meet raw material specifications.

    Product
    Medicina Reusable Oral syringe 1ml Code: OTH01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2021·2021-07-28

    Medical dialysis concentrates recalled for freezing temperature exposure

    Fresenius Medical Care recalls Citrasate and NaturaLyte hemodialysis acid concentrates due to exposure to freezing temperatures during refrigerated truck transport. The affected products were distributed exclusively to Texas.

    Product
    Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are each intended to be used as one component in the preparation of dialysate in a 3-stream proportioning hemodialysis machine according to a physician s prescription. Both concentrates are formulated for us
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1887-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welding

    Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.

    Product
    Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.

    Product
    Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2160-2018·2018-06-20

    Maquet Aortic Arterial Cannula Recall Due to De-airing Plug Defect

    Maquet is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.

    Product
    Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0663-2018·2018-02-28

    Zimmer NexGen LPS Femoral Component Recalled for Packaging Defect

    Zimmer is recalling 7 NexGen LPS Femoral Components because undersized foam inserts may allow the inner cavity to breach during shipping.

    Product
    NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1256-2016·2016-04-06

    ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak

    ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.

    Product
    30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0515-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0132-2015·2014-11-05

    Maquet Cardiovascular Recalls Cardiac Surgery Systems Due to Tyvek Pouch Defects

    Maquet Cardiovascular is recalling specific cardiac surgery systems because internal findings identified pinholes or cuts in Tyvek pouches within the vacuum tubing sets.

    Product
    Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2014·2014-03-05

    Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect

    Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.

    Product
    ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2013·2013-06-12

    Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues

    Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.

    Product
    FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2013·2012-11-28

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications

    Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.

    Product
    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration
    Category
    Medical Device
    Distribution
    Distributed nationwide