The Recall Desk

Hazard

Loss Of Sterility recalls

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

What the numbers show

Total
333
Critical
26
Severe
45
Most recent
2026-08-12

Of the 333 loss of sterility recalls we have scored against our rubric, 26 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (14%) 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 loss of sterility 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.

51–75 of 333

  • HighFDA (Devices)·Z-0288-2020·2019-11-13

    Argon Medical Devices Recalls Sterile Adapters Due to Seal Defects

    Argon Medical Devices is recalling specific lots of sterile double female and male luer lock adapters because incomplete pouch seals may compromise sterility.

    Product
    (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

    Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.

    Product
    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2004-2019·2019-07-31

    Terumo 18G Needles Recalled for Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 810,000 18G needles due to a potential loss of package integrity that may compromise sterility.

    Product
    Terumo Needle, 18G x 1", Product Code NN1825R
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1999-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 444,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 22G x 1", Product Code 100211
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1998-2019·2019-07-31

    Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity

    Terumo Medical Corporation is recalling 729,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.

    Product
    Terumo Sur-vet Needle, 20G x 1", Product Code 100204
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-0319-2019·2018-12-26

    GE Healthcare Recalls Omnipaque Injection Due to Vial Defect

    GE Healthcare is recalling 1,092 cartons of Omnipaque (iohexol) Injection in Tennessee due to a vial defect that could compromise sterility or introduce glass particles.

    Product
    OMNIPAQUE — OMNIPAQUE (IOHEXOL)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0216-2019·2018-11-14

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0378-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2 due to a potential pouch seal failure that could compromise sterility.

    Product
    Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0095-2019·2018-10-31

    Pfizer Recalls Meropenem Injection Due to Loss of Sterility Assurance

    Pfizer is recalling 71,075 vials of Meropenem for Injection because the containers may have lost integrity, compromising sterility.

    Product
    Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 24 units of Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3045-2018·2018-09-19

    Beaver Accu-Temp High Temperature Cautery Recalled for Sterility Risk

    Beaver Visitec is recalling 800 units of Accu-Temp High Temperature Cautery devices due to a potential loss of sterility caused by packaging defects.

    Product
    Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0961-2018·2018-07-25

    Avella Recalls Norepinephrine Bags Due to Potential Leakage

    Avella of Deer Valley is recalling 1,290 bags of Norepinephrine Bitartrate 4 mg due to potential leakage and lack of sterility assurance.

    Product
    NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0937-2018·2018-07-25

    Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 1,860 bags of Midazolam 1 mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0896-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1639-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1634-2018·2018-05-16

    Vygon Recalls Neonatal PICC Trays Due to Potential Sterility Issues

    Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.

    Product
    Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0604-2018·2018-03-28

    Fresenius Recalls DELFLEX Peritoneal Dialysis Solution Due to Bag Leakage

    Fresenius Medical Care is recalling specific lots of DELFLEX Peritoneal Dialysis Solution because bag leakage may compromise sterility.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0906-2018·2018-03-14

    Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns

    Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.

    Product
    2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2018·2018-03-14

    Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.

    Product
    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2018·2018-03-07

    Alto Development Corp Recalls Surgical Punches Due to Packaging Damage

    Alto Development Corp is recalling surgical punches because packaging damage during transport may have compromised sterility.

    Product
    Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0957-2017·2017-07-19

    Baxter Recalls Sodium Chloride Injection Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection bags due to customer complaints about leaking bags, which raises concerns about the product's sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2017·2017-05-24

    Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.

    Product
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2017·2017-05-24

    Medline Recalls 10 mm Distraction Pins Due to Sterile Seal Concerns

    Medline Industries is recalling 10 mm Distraction Pins because the sterile packaging seal may be compromised, potentially causing the device to lose sterility.

    Product
    10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fix
    Category
    Medical Device
    Distribution
    Distributed nationwide