The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

1201–1225 of 2228

  • HighFDA (Devices)·Z-1326-2017·2017-03-08

    Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 225 Lap Gallbladder Packs because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Lap Gallbladder Pack, part number AMS3707
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1233-2017·2017-03-01

    Degania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise

    Degania Silicone is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round because the sterile barrier was breached, compromising sterility.

    Product
    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1195-2017·2017-02-22

    Argon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling T-LOK bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2017·2017-02-22

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2017·2017-02-22

    Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns

    Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility. The recall affects units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1136-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 105 Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1132-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 499 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 275 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1130-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall affects 180 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1134-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1135-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0889-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.

    Product
    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.

    Product
    Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0821-2017·2016-12-28

    Stanmore Implants Recalls Tibial Components Due to Packaging Puncture

    Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.

    Product
    Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0852-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 50 units of Low Profile Abutments because some pouches may not have been sealed during packaging.

    Product
    BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0880-2017·2016-12-28

    Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure

    Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.

    Product
    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0836-2017·2016-12-28

    Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

    Biomet 3i is recalling 101 units of a specific dental implant abutment because some product pouches may not have been sealed during packaging.

    Product
    BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0751-2017·2016-12-21

    Integra York Recalls Sterile Rochester-Pean Hemostatic Forceps Due to Seal Defect

    Integra York PA, Inc. is recalling 150 units of sterile Rochester-Pean Hemostatic Forceps because packaging seals may separate, compromising sterility.

    Product
    Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
    Category
    Medical Device
    Distribution
    2 states