The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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.

1751–1775 of 2235

  • HighFDA (Devices)·Z-2772-2015·2015-09-23

    Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects

    Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.

    Product
    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2527-2015·2015-09-09

    Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2536-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise

    FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.

    Product
    MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2534-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2537-2015·2015-09-09

    Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns

    Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2535-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise

    Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2526-2015·2015-09-09

    Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2533-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2015·2015-09-09

    Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling specific Mahurkar Elite Acute Dual Lumen Catheter Trays because their sterility may be compromised.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. This Class II recall affects a specific lot distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2530-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 53 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2015·2015-09-09

    Monoject Saline Flush Recall Due to Potential Sterility Compromise

    Covidien LLC is recalling Monoject 0.9% Saline Flush Prefill Double Pouches because sterility may be compromised.

    Product
    Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2528-2015·2015-09-09

    Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2531-2015·2015-09-09

    Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.

    Product
    Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1384-2015·2015-09-02

    Liberty Drug Recalls Papaverine/Phentolamine/PGE-1 Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable because process deficiencies may have compromised sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1395-2015·2015-09-02

    Liberty Drug Recalls Dexamethasone Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 22 vials of Dexamethasone 24 mg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1391-2015·2015-09-02

    Liberty Drug Recalls 17-Hydroxyprogesterone Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone injectable because process deficiencies may have compromised sterility.

    Product
    17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1403-2015·2015-09-02

    Liberty Drug Recalls Lidocaine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Lidocaine/Sodium Chloride injectable vials because process deficiencies may have compromised sterility.

    Product
    Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1393-2015·2015-09-02

    Liberty Drug Recalls Papervine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papervine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised sterility.

    Product
    Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1397-2015·2015-09-02

    Liberty Drug Recalls Glycerin Injection Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Glycerin 72% Injection vials because process deficiencies may have compromised sterility. The product was distributed to physicians and facilities in NJ and NY.

    Product
    Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1390-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 58 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1382-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Methylcobalamin 5000 mcg/mL Injectable vials due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1400-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/Atropine/PGE-1 Injectable due to process deficiencies that could compromise sterility.

    Product
    Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1387-2015·2015-09-02

    Liberty Drug Recalls Vancomycin Ophthalmic Solution Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's sterility.

    Product
    Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1385-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states