The Recall Desk

Hazard

Foreign Body Reaction recalls

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

What the numbers show

Total
15
Critical
0
Severe
3
Most recent
2024-11-20

Of the 15 foreign body reaction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (20%) 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 foreign body reaction 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.

1–15 of 15

  • HighFDA (Devices)·Z-0402-2025·2024-11-20

    Medical surgical kits recalled for loose metal flakes in instruments

    AVID Medical is recalling Halyard CYSTO PDS medical convenience kits due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could enter a surgical site and cause foreign body reactions.

    Product
    Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2025·2024-11-20

    Surgical Kit Components Recalled for Potential Metal Fragment Detachment

    AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.

    Product
    Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2025·2024-11-20

    Halyard FOOT ANKLE PACK surgical instruments recalled due to loose metal flakes

    AVID Medical recalls Halyard FOOT ANKLE PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps that could enter surgical sites and cause local reactions.

    Product
    Halyard FOOT ANKLE PACK - Medical convenience kits Model Number: EUOR005-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2025·2024-11-20

    Halyard Urology Laparotomy Pack surgical instruments recalled for detachable metal flakes

    AVID Medical recalls Halyard Urology Laparotomy Pack surgical instruments (Model SAMM023-13, Lot 1595070) due to loose metal flakes that could detach from forceps and clamps, potentially entering surgical sites and causing foreign body reactions.

    Product
    Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number: SAMM023-13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2025·2024-11-20

    Halyard EYE PLASTIC TRAY Medical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.

    Product
    Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2025·2024-11-20

    Halyard Surgical Kit Components May Shed Metal Flakes

    AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0996-2023·2023-01-25

    Vasoshield Syringe Packs Recalled Due to Chipping Ink Risk

    Maquet Cardiovascular is recalling Vasoshield Syringe Packs (Model VH-5001) because ink on the syringe logo may chip, creating a risk of foreign body complications and embolic events. The recall affects 530 units in the United States and 215 units outside the United States.

    Product
    Vasoshield Syringe Packs, Model VH-5001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0201-2023·2022-11-23

    Endo Stitch V-Loc surgical sutures recalled due to needle breakage

    Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.

    Product
    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2023·2022-11-16

    Medical Device Recall: ORISE Gel Submucosal Lifting Agent Due to Foreign Body Reactions

    Boston Scientific is recalling ORISE Gel Submucosal Lifting Agent due to higher incidence of foreign body reactions to retained gel. These reactions caused mass formations requiring surgical intervention.

    Product
    ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0225-2023·2022-11-16

    ORISE Gel Syringe Recall Due to Foreign Body Reaction Risk

    Boston Scientific has recalled ORISE Gel Syringe kits used in gastrointestinal endoscopy due to higher incidence of foreign body reactions from remnant gel requiring surgical intervention.

    Product
    ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0226-2023·2022-11-16

    Medical Device Procedure Kits Recalled for Foreign Body Reaction Risk

    Boston Scientific recalls ORISE ProKnife Procedure Kits due to higher incidence of foreign body reactions to remnant gel post-procedure, which have required surgical intervention in affected patients.

    Product
    ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2204-2016·2016-07-20

    Stryker Recalls 5.0mm Round Fluted Burs Due to Corrosion Risk

    Stryker Instruments is voluntarily recalling specific lots of 5.0mm Round Fluted Burs because tarnishing or corrosion may cause inflammation requiring surgery.

    Product
    5.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2205-2016·2016-07-20

    Stryker Recalls Specific Lots of Round Fluted Burs Due to Corrosion

    Stryker is voluntarily recalling specific lots of 6.0mm Round Fluted Burs due to potential tarnishing or corrosion that could cause inflammation requiring surgery.

    Product
    6.0mm Round Fluted Bur, Super Long
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1082-2016·2016-03-16

    Biomet Recalls Crosslock DVR ePAK Surgical Sets Due to Oxidation Risk

    Biomet is recalling 21,268 Crosslock DVR ePAK surgical sets because components may oxidize during storage. This could cause an inflammatory reaction if material enters the surgical wound.

    Product
    Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radiu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2013·2013-09-04

    Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant

    Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.

    Product
    Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-settin
    Category
    Medical Device
    Distribution
    Distributed nationwide