The Recall Desk

Hazard

Contamination Risk recalls

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

What the numbers show

Total
993
Critical
2
Severe
112
Most recent
2026-08-12

Of the 993 contamination risk recalls we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 112 (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 contamination risk 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 993

  • HighFDA (Devices)·Z-2749-2024·2024-09-04

    Medline Circumcision Tray Kits Recalled for Defective Syringes

    Medline procedural kits containing circumcision trays are being recalled due to plastic syringes affected by an FDA Safety Alert. The syringes have identified leaks and breakage that may pose risks to patient health.

    Product
    Medline procedural kits labeled as: CIRCUMCISION TRAY, Pack Number DYNDA2271
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2641-2024·2024-08-28

    Bottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects

    Microtek Medical Inc. is recalling Bottle Decanter REF 2004S units due to pin holes and tears found in the sterile barrier packaging during testing. Compromised packaging could allow contamination of the medical device.

    Product
    Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2640-2024·2024-08-28

    Bag Decanter II Medical Device Recalled for Sterile Packaging Defects

    Microtek Medical Inc. is recalling Bag Decanter II medical devices due to pinholes and tears identified in the sterile packaging film during quality testing, which could compromise product sterility.

    Product
    Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2685-2024·2024-08-28

    Regard Kit Decanters Recalled for Defective Sterile Packaging

    ROi CPS LLC is recalling 78 Regard Kits containing Microtek decanters due to pin holes and tears in sterile packaging that cannot be identified visually. Defective packaging could compromise the sterile barrier.

    Product
    Regard Kit containing the Microtek decanter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2024·2024-08-28

    Vial Decanter Medical Device Recalled for Compromised Sterile Packaging

    Microtek Medical Inc. recalls Vial Decanter units (REF 2006S) due to pin holes and tears in the sterile packaging film discovered during testing. Compromised sterile barriers could allow microbial contamination.

    Product
    Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2024·2024-08-28

    C-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall

    Microtek Medical Inc. recalls C-Flow Bag Decanters (10,366 cases) due to pin holes and tears in sterile barrier packaging discovered during quality testing. The defects could allow bacterial contamination.

    Product
    C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2024·2024-08-14

    Estradiol Cypionate Injection Recalled Due to Lack of Sterility Assurance

    Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.

    Product
    Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2539-2024·2024-08-14

    Medical Device Hookup Instructions Contain Errors Affecting Endoscope Disinfection

    Steris Corporation recalls certain automated endoscope reprocessor hookups due to incorrect instructions in product documentation. Improper hookup connection could prevent proper endoscope disinfection, risking patient infection.

    Product
    Hookup Model/Catalog Number: DSD-110-HU0163 Product Description: Hookups provide the interface between DSD Automated Endoscope Reprocessors ( AER ) and endoscopes, which allow perfusion of liquids dispensed by the AER to contact and high-level disinfect the channels of flexib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1627-2024·2024-08-14

    Non-Alcoholic Cocktail Mixer Recalled Due to Facility Safety Concerns

    Cafe Caramel Delight, a non-alcoholic cocktail mixer, is being recalled because it was produced in an unlicensed, uninspected facility with potential under-processing concerns.

    Product
    Cafe Caramel Delight is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-1631-2024·2024-08-14

    Urban River Spirits Cocktail Mixer Recalled for Under-Processing Risk

    Urban River Spirits is recalling Tropical Lime & Coconut non-alcoholic mixer because it was manufactured in an unlicensed facility with potential under-processing. No illnesses have been reported.

    Product
    Tropical Lime & Coconut is a non-alcoholic cocktail mixer. Product is packaged in glass 750ml bottle and sold under brand Urban River Spirits. Label has listed instructions as Shake Well Refrigerated After Opening.
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2406-2024·2024-07-24

    Surgical Hemostatic Device Recalled for Compromised Sterile Barrier

    Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2024·2024-07-24

    High Flow Insufflation Tubing Recalled for Incomplete Seals

    Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.

    Product
    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2407-2024·2024-07-24

    Surgical Product Recalled Due to Torn Pouches Compromising Sterile Barrier

    Ethicon Sarl is recalling SURGICEL FIBRILLAR product due to torn foil pouches that compromised the sterile barrier. Approximately 39,010 units distributed in the US, India, and Japan are affected.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0608-2024·2024-07-24

    Peritoneal Dialysis Solution Recalled for Tube Weld Failure Risk

    Fresenius is recalling DELFLEX dialysis solution due to tube weld failures causing slow leaks that are difficult to detect. 183 cases affected nationwide.

    Product
    DELFLEX — DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2024·2024-07-10

    Medline surgical convenience kits recalled due to weak Pure Pouch seals

    Medline is recalling over 7,600 Open Heart surgical convenience kits nationwide due to weak seals on the Pure Pouch component. The seals may fail and compromise the sterility of the surgical instruments inside.

    Product
    Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2226-2024·2024-07-10

    Medline Neuro IR Surgical Kit Recalled Due to Weak Seals

    Medline is recalling Neuro IR surgical convenience kits due to weak seals in the Pure Pouch component that may compromise sterility. The recall affects 12,588 kits distributed nationwide.

    Product
    Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2024·2024-07-10

    Medline surgical convenience kits recalled for weak seal integrity

    Medline surgical convenience kits containing Pure Pouch components with weak seals may fail to maintain sterility, potentially compromising the safety of contained medical instruments. Affected kits were distributed nationwide across 23 states.

    Product
    Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reorder #DYNJ040408, Kelly Forceps/STD STR Sterile. b. Medline Adult/Child Intubation Kit, Pack #ACC010616 and Pack #ACC010616H, containing a P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2024·2024-07-10

    Medline Birthing Room Pack surgical kits recalled due to weak sterile seals

    Medline is recalling approximately 12,588 sterile surgical kits used for childbirth procedures because weak seals on Pure Pouch components may fail and compromise sterility.

    Product
    Sterile convenience kit: Medline Birthing Room Pack, Pack #DYNJ38429D, containing a Pure Pouch component Sterile Sharp/Blunt Scissors 5.5", Reorder #65945 and containing a Pure Pouch component Sterile 5.5" Episiotomy Scissors, Reorder #67645.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0547-2024·2024-06-19

    Klarity-C Ophthalmic Emulsion Recalled Due to Sterility Assurance Risk

    Imprimis is recalling Klarity-C, a cyclosporine eye medication, because the company cannot assure the product meets sterility standards. Approximately 136,005 units were distributed nationwide.

    Product
    Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852 NDC: 71384-514-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0509-2024·2024-06-05

    Cathflo Activase Injection Vials Recalled Due to Deformed Stoppers

    Genentech is recalling Cathflo Activase injection vials in two lots due to deformed stoppers found during manufacturing that compromise sterility assurance.

    Product
    CATHFLO ACTIVASE — CATHFLO ACTIVASE (ALTEPLASE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0510-2024·2024-06-05

    Zoledronic Acid Injection Recalled for Sterility Defect

    Dr. Reddy's Laboratories recalls Zoledronic Acid Injection 5mg/100mL due to lack of sterility assurance and leaking vials. Lot #G3000010 with 13,880 vials was distributed nationwide.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2024·2024-05-29

    SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals

    Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.

    Product
    SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2024·2024-05-29

    Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes

    Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2024·2024-05-22

    Medtronic Tourniquet Sets recalled for potential unsealed sterile packing

    Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.

    Product
    Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1800-2024·2024-05-22

    Medtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing

    Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.

    Product
    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-
    Category
    Medical Device
    Distribution
    0 states