The Recall Desk

Hazard

Manufacturing Defect recalls

1,441 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,441
Critical
7
Severe
114
Most recent
2026-10-21

Of the 1,441 manufacturing defect recalls we have scored against our rubric, 7 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 114 (8%) 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 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.

426–450 of 1441

  • HighFDA (Devices)·Z-2518-2023·2023-09-13

    Trocar with oversized shaft obscures surgical view in brain operations

    Aesculap trocars manufactured with shafts too long obstruct the visual field when used with neuroendoscopes in brain surgery. Affected units distributed in nine states should not be used.

    Product
    For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2023·2023-09-06

    LifeSPARC Cardiac Pump Recalled Due to Uncured Epoxy Manufacturing Defect

    Cardiac Assist, Inc. is recalling the LifeSPARC Pump due to uncured epoxy used during manufacturing that may cause early device failure. Two units were distributed in Illinois and Florida.

    Product
    LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1125-2023·2023-09-06

    FDA Recalls Phenylephrine IV Bags Due to Sterility Validation Concerns

    Central Admixture Pharmacy Services is recalling 586 bags of phenylephrine IV solution due to lack of validation data for sterilization cycles. These bags may not meet sterility assurance requirements for intravenous use.

    Product
    PHENYLephrine, added to 0.9% sodium chloride, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1087-2023·2023-08-30

    Rufinamide 200 mg Tablets Recalled for Manufacturing Process Deviation

    Aurobindo Pharma USA Inc. is recalling Rufinamide 200 mg tablets (Lot RB2023001A) because a batch was released prior to manufacturing approval. The FDA classified this as a Class II recall.

    Product
    RUFINAMIDE — RUFINAMIDE (RUFINAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1101-2023·2023-08-30

    FDA Recalls AstrinGyn Surgical Hemostatic Due to Manufacturing Practice Deviations

    Ecometics is recalling 92,967 vials of AstrinGyn (Ferric Subsulfate) Aqueous due to manufacturing practice violations. The product was not manufactured under current good manufacturing practices (CGMP).

    Product
    AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manufactured for CooperSurgical, Trumbull, CT 06611, NDC 59365-6065-0, Ref 6065.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2023·2023-08-30

    FilmArray Pneumonia Panel Recalled Due to Manufacturing Defect Causing False Negatives

    BioFire Diagnostics recalled FilmArray Pneumonia Panel diagnostic kits due to a manufacturing defect that may produce false negative results, potentially causing missed pneumonia diagnoses.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-1090-2023·2023-08-30

    Helix Pain Relieving Cream recalled nationwide for manufacturing process violations

    Parker Laboratories is recalling Helix Pain Relieving Cream due to manufacturing process deviations. The voluntary recall affects multiple package sizes distributed nationwide and internationally.

    Product
    Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03), c) 4 fl. oz. tubes (NDC 30775-051-04), d) 12 fl oz pump bottles (NDC 30775-051-12), e) 32 fl. oz. pump bottles (NDC 30775-051-32), f) 1 U.S. gallon…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2023·2023-08-30

    Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations

    Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.

    Product
    Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2420-2023·2023-08-23

    Endoscopic surgical clamp recalled for defective rotation knob

    Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS DIAMOND-TOUCH surgical clamps because the rotation knob may crack or break due to a manufacturing defect. Lots B23 and C23 are affected.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2424-2023·2023-08-23

    Endoscopic surgical grasper recalled due to rotation knob defect

    Carefusion is recalling specific lots of Snowden-Pencer Diamond-Touch endoscopic graspers due to a manufacturing defect that may cause the rotation knob to crack or break. Affected units were distributed in the US and Canada.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2418-2023·2023-08-23

    Endoscopic Dissector Surgical Tool Recalled for Cracking Knob Defect

    Carefusion 2200 Inc is recalling Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR endoscopic surgical instruments due to potential cracking of the rotation knob from incorrect adhesive use in manufacturing. Lot B23 is affected.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2428-2023·2023-08-23

    Endoscopic Surgical Grasper Recalled for Potential Rotation Knob Cracking

    Carefusion is recalling specific lots of surgical graspers due to potential cracking of the rotation knob caused by incorrect adhesive use in manufacturing. Affected devices may fail during surgical procedures.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2423-2023·2023-08-23

    Surgical grasper recalled for rotation knob cracking due to adhesive defect

    Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in the US and Canada.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2416-2023·2023-08-23

    Endoscopic Grasper Instrument Recalled for Rotation Knob Failure Risk

    Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer DIAMOND-TOUCH GRASPER endoscopic surgical instrument due to a manufacturing defect that may cause the rotation knob to crack or break, potentially compromising surgical performance.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2415-2023·2023-08-23

    Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob

    Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2422-2023·2023-08-23

    Endoscopic Surgical Clamp Recalled Due to Potential Rotation Knob Failure

    Carefusion is recalling specific lots of Snowden-Pencer MIS endoscopic surgical clamps due to potential cracking or breaking of the rotation knob caused by incorrect adhesive use during manufacturing.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2419-2023·2023-08-23

    Surgical clamp rotation knob may crack or break due to manufacturing defect

    Specific lots of Snowden-Pencer surgical clamps may have rotation knobs that crack or break due to incorrect adhesive use in manufacturing. Eight units with lot numbers L22, B23, or C23 distributed in the US and Canada are affected.

    Product
    Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2023·2023-08-09

    Intraocular Lenses Recalled Due to Unintended Fiducial Marks

    Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.

    Product
    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2288-2023·2023-08-09

    TECNIS Symfony Intraocular Lenses Recalled for Unintended Fiducial Marks

    Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.

    Product
    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1027-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.

    Product
    CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2023·2023-07-26

    RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences

    FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.

    Product
    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2023·2023-07-19

    Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions

    Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.

    Product
    Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0922-2023·2023-07-19

    Artificial Tears Eye Drops Recalled Due to Manufacturing Facility Contamination

    Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.

    Product
    Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0915-2023·2023-07-19

    Hand Sanitizer Recalled for Impurities Exceeding Allowable Limits

    Big Machine Distillery Hand Sanitizer is being recalled due to manufacturing impurities exceeding allowable limits. No illnesses or injuries have been reported.

    Product
    Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon…
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-2128-2023·2023-07-19

    Abiomed Introducer Set Recall Due to Sidearm Detachment Risk

    Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.

    Product
    Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
    Category
    Medical Device
    Distribution
    Distributed nationwide