The Recall Desk

Hazard

Manufacturing Defect recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all manufacturing defect 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.

101–125 of 917

  • HighFDA (Devices)·Z-0571-2026·2025-11-26

    Greiner Vacuette Blood Collection Tubes Manufactured Without Required Gel Separator

    Greiner Bio-One is recalling 1.98 million Vacuette blood collection tubes manufactured without gel separator. The missing component can yield erroneous test results, requiring repeat testing and potentially delaying diagnosis.

    Product
    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0567-2026·2025-11-26

    Medical Device Collection Tube Extender Recalled for Manufacturing Deficiencies

    ASP Global is recalling the SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004, due to manufacturing under an inadequate quality system with unvalidated processes. The recall affects 27,100 units distributed in the US and Canada.

    Product
    SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0168-2026·2025-11-26

    KleenFoam Antimicrobial Foam Soap Recalled Due to Manufacturing Control Deviation

    DermaRite Industries is recalling KleenFoam Antimicrobial Foam Soap cartridges due to manufacturing control (CGMP) deviations at the facility where contamination was found in other product lots. The product is distributed nationwide.

    Product
    KleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2026·2025-11-26

    MONARCH Bronchoscope May Lack Adequate Leak Resistance Due to Testing Defect

    Approximately 1,477 MONARCH Bronchoscope units (Model MBR-000211-B) may not properly resist leaks due to inadequate leak testing with equipment operating outside its normal range. The affected devices were distributed nationwide to medical facilities.

    Product
    MONARCH Bronchoscope. Model Number: MBR-000211-B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2026·2025-11-26

    Capillary Blood Collection Device Recalled for Manufacturing Quality Deficiency

    ASP Global is recalling SAFE-T-FILL Micro Capillary Blood Collection devices (Model 07 7251) due to inadequate quality system and unvalidated manufacturing processes. Approximately 6,050 units were distributed nationwide in the US and Canada.

    Product
    SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0565-2026·2025-11-26

    Magnetic Rings for Blood Gas Capillaries Recalled Due to Manufacturing Defect

    ASP Global is recalling SAFE-T-FILL Magnetic Rings for blood gas capillaries (Model 07 9502) due to manufacturing under an inadequate quality system with unvalidated processes. Approximately 16,920 units were distributed nationwide and in Canada.

    Product
    SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2026·2025-11-26

    Capillary Blood Collection Device Recalled Due to Manufacturing Quality Issues

    ASP Global recalled approximately 49,000 SAFE-T-FILL Micro Capillary Blood Collection devices distributed nationwide and in Canada due to manufacturing under an inadequate quality system with unvalidated processes.

    Product
    AFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7220 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2026·2025-11-26

    SAFE-T-FILL End Caps for Blood Gas Capillaries Manufacturing Deficiency Recall

    ASP Global is recalling SAFE-T-FILL End Caps for blood gas capillaries manufactured under an inadequate quality system with unvalidated processes. Approximately 620,502 units distributed in the US and Canada may be affected.

    Product
    SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2026·2025-11-26

    SAFE-T-FILL MicroHematocrit Capillary Tubes Recalled for Manufacturing Defects

    ASP Global recalls SAFE-T-FILL MicroHematocrit Capillary Tubes due to manufacturing under inadequate quality systems with unvalidated processes. No illnesses or injuries have been reported.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0163-2026·2025-11-26

    DermaKleen Antiseptic Soap Recalled Due to Manufacturing Defect Risk

    DermaKleen Health Care Antiseptic Lotion Soap is being recalled nationwide due to a Current Good Manufacturing Practice (CGMP) deviation at the manufacturer. The facility previously produced contaminated lots of other products.

    Product
    DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0556-2026·2025-11-26

    Capillary tubes recalled for inadequate manufacturing quality system

    SAFE-T-FILL MicroHematocrit Capillary Tubes are being recalled due to the manufacturer's inadequate quality system and unvalidated manufacturing processes.

    Product
    SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2026·2025-11-26

    Antifungal Cream Recall Due to Manufacturing Facility Contamination

    DermaFungal Antifungal Cream is being recalled because it was manufactured at a facility with CGMP violations and confirmed contamination of other products. The recall affects all lots distributed nationwide.

    Product
    DermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0557-2026·2025-11-26

    SAFE-T-FILL Plastic Blood Gas Capillary Tubes Recalled for Manufacturing Quality Defects

    ASP Global is recalling 397,000 SAFE-T-FILL Plastic Blood Gas Capillary Tubes due to manufacturing and quality system defects that were not validated before production. The recall affects tubes distributed nationwide in the US and Canada.

    Product
    SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Balanced Heparin Model 06 0186 Product Description: A clear, plastic capillary blood collection tube coated with Heparin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2026·2025-11-19

    CombiDiagnost R90 Ceiling Carriages Recalled for Vertical Movement Defect

    Philips recalls 17 CombiDiagnost R90 ceiling suspension carriages due to manufacturing defects that may impair vertical movement. Affected units may be difficult to operate, requiring additional physical force for normal manual movement.

    Product
    CombiDiagnost R90; Model Number: 709031;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2026·2025-11-19

    Ceiling suspension carriages recalled due to movement difficulty

    Philips Medical Systems is recalling ProxiDiagnost N90 ceiling suspension carriages due to manufacturing defects that may cause difficulty moving the units vertically. The affected units require additional physical effort to operate.

    Product
    ProxiDiagnost N90; Model Number: 706110;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2026·2025-11-19

    Philips Ceiling Suspension Carriage Difficult to Move Vertically

    Philips Medical Systems is recalling 42 units of ceiling suspension carriages (Model 706400) distributed worldwide due to manufacturing defects causing difficulty moving vertically and requiring excessive physical exertion.

    Product
    Precision CRF; Model Number: 706400;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0464-2026·2025-11-19

    Philips DigitalDiagnost 4 Ceiling Suspension Carriage May Be Difficult to Move

    Philips is recalling DigitalDiagnost 4 ceiling suspension carriages that may require excessive force to move vertically due to manufacturing issues. Approximately 12 affected units were manufactured from July 2024 through June 2025.

    Product
    DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 712031, (2) 712032;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2026·2025-11-05

    MEGA Ballast Catheter Recalled Due to Coating Material Defect

    The FDA is recalling 207 MEGA Ballast catheters due to a manufacturing defect causing coating material to lift within the catheter's lumen. The recall affects units distributed in 12 US states.

    Product
    Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Drugs)·D-0133-2026·2025-11-05

    Testosterone/Triamcinolone injectable pellets recalled for potential metal contamination

    FarmaKeio Outsourcing is recalling testosterone/triamcinolone injectable pellets due to potential metal particulate matter from manufacturing deviations. Patients should contact their healthcare provider about affected lot numbers.

    Product
    Testosterone / Triamcinolone Acetonide 50MG/10MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0365-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2026·2025-11-05

    FDA Recalls Desipramine Tablets Due to N-Nitroso Impurity

    Heritage Pharmaceuticals is recalling Desipramine Hydrochloride 75 mg tablets nationwide due to manufacturing deviations resulting in N-Nitroso impurity exceeding acceptable levels. Patients should consult their pharmacist or doctor regarding their medication.

    Product
    DESIPRAMINE HYDROCHLORIDE — DESIPRAMINE HYDROCHLORIDE (DESIPRAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0125-2026·2025-11-05

    Testosterone pellets recalled for potential metal particulate contamination

    FarmaKeio Outsourcing is recalling Testosterone 62.5 MG pellets (Lot 3180) due to potential metal particulate matter from manufacturing deviations. Product was distributed nationwide.

    Product
    Testosterone 62.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0383-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0130-2026·2025-11-05

    Testosterone/Triamcinolone pellets recalled for potential metal contamination

    FarmaKeio Outsourcing is recalling Testosterone/Triamcinolone Acetonide pellets due to potential metal particulate matter from manufacturing deviations. The recall affects 18,124 pellets distributed nationwide.

    Product
    Testosterone / Triamcinolone Acetonide, 12.5MG/2.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0363-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0140-2026·2025-11-05

    FDA Recalls Everolimus Tablets Due to Out-of-Specification Impurity

    Endo USA is recalling 1,866 cartons of Everolimus 7.5mg tablets nationwide due to out-of-specification impurity levels in affected lots.

    Product
    EVEROLIMUS — EVEROLIMUS (EVEROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0139-2026·2025-11-05

    Endo USA Recalls Everolimus Tablets for Out-of-Specification Impurity

    Endo USA is recalling Everolimus 5mg tablets nationwide due to out-of-specification impurity levels. Affected consumers should consult their healthcare provider about their treatment plan.

    Product
    EVEROLIMUS — EVEROLIMUS (EVEROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide