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.

151–175 of 293

  • ModerateFDA (Devices)·Z-2330-2016·2016-08-10

    Dako EnVision FLEX+ Mouse High pH Kits Recalled for pH Error

    Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.

    Product
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·16E059000·2016-06-23

    Waterous Recalls Split-Shaft Transmission Shift Units for Emergency Vehicles

    Waterous is recalling specific Split-Shaft Transmission Shift Units used in emergency response vehicles. A damaged component may prevent operators from switching power output, potentially hindering fire suppression efforts.

    Product
    POWER TRAIN:MANUAL TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1940-2016·2016-06-15

    Alcon Recalls CENTURION FMS Packs Due to Molding Irregularity

    Alcon is voluntarily removing specific lots of CENTURION FMS packs due to a molding irregularity that may reduce vacuum in the aspiration line.

    Product
    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1910-2016·2016-06-15

    Stryker FlowPort II Adapter Recalled Due to Incorrect Orientation

    Stryker is recalling 21 FlowPort II Adapters because the arthroscope sits in the adapter 180 degrees in the wrong direction.

    Product
    Stryker FlowPort II Adapter: Model number: 00CAT00778 The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1839-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,804 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 6,128 COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2016·2016-06-08

    Baxter Recalls COSEAL Surgical Sealant Kits Due to Dissolution Issues

    Baxter Healthcare is recalling 274 units of COSEAL Surgical Sealant Kits because the PEG component may not fully dissolve, affecting hydrogel consistency.

    Product
    COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2016·2016-05-11

    Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage

    Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.

    Product
    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2016·2016-04-20

    Bard TruGuide Biopsy Needle Recall Due to Incorrect Stylet Size

    Bard Peripheral Vascular is recalling TruGuide Disposable Coaxial Biopsy Needles because they may contain an incorrectly sized blunt tip stylet that will not pass through the coaxial.

    Product
    Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1333-2016·2016-04-13

    Karl Storz Endoscope Cleaning Brush Recalled for Fit Issues

    Karl Storz is recalling 16,908 endoscope cleaning brushes because they may not fit into the endoscope channel, preventing proper cleaning.

    Product
    ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2016·2016-04-06

    Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect

    Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2016·2016-04-06

    Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

    Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2016·2016-03-30

    Anspach Effort Recalls Irrigation Clip 30 Due to Incorrect Assembly

    The Anspach Effort, Inc. is recalling Irrigation Clip 30 units assembled with incorrect smaller front clips. The affected clips were distributed in Pennsylvania, Minnesota, and Switzerland.

    Product
    Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2016·2016-02-17

    Salter Labs Recalls T-piece Nebulizers Due to Fit Issues

    Salter Labs is recalling 70 T-piece Nebulizers because the T-piece does not fit on the nebulizer. The devices were distributed in six US states and China.

    Product
    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0699-2016·2016-02-10

    Smith & Nephew Recalls Oversized Biosure Orthopedic Screw Drivers

    Smith & Nephew is recalling 157 Biosure Drivers that are oversized and may fail to insert screws properly or cause screws to stick.

    Product
    Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0700-2016·2016-02-10

    Smith & Nephew Recalls Oversized Biosure Ratchet Driver for Orthopedic Screws

    Smith & Nephew is recalling nine Biosure Ratchet Drivers because they are oversized and may not fit screws properly or may cause screws to stick.

    Product
    Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2016·2016-01-13

    Siemens Acute Care DDMR TestPak Barcode Scanning Recall

    Siemens Healthcare Diagnostics is recalling Acute Care DDMR TestPaks because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2016·2015-12-30

    Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression

    Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.

    Product
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
    Category
    Medical Device
    Distribution
    4 states