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.

51–75 of 917

  • HighFDA (Drugs)·D-0352-2026·2026-03-04

    BioGlo Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Concerns

    The FDA has recalled 184,320 containers of BioGlo Fluorescein Sodium Ophthalmic Strips nationwide due to lack of sterility assurance resulting from manufacturing non-compliance. Consumers should stop using the product and consult a healthcare provider.

    Product
    BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2026·2026-03-04

    Fluorescein Sodium Ophthalmic Strips Recalled for Sterility Assurance Defect

    Wizcure Pharmaa's Fluorescein Sodium Ophthalmic Strips have been recalled nationwide due to lack of assurance of sterility from manufacturing non-conformance with current good manufacturing practices. All lots are affected.

    Product
    C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS — C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V233000·2026-03-03

    2025 Peterbilt and Kenworth trucks recalled for steering gear defect

    PACCAR is recalling certain 2025 Peterbilt and Kenworth trucks because the steering gear sector shaft was improperly heat-treated, which can cause cracking that leads to loss of steering control. Dealers will replace the affected gears at no cost.

    Product
    PETERBILT — 2025 PETERBILT 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2026·2026-02-25

    Medline Lithotomy Packs Recalled for Sterilization Equipment Calibration Issues

    Medline has recalled lithotomy packs due to calibration issues with sterilization equipment that may compromise sterility assurance. Affected units were distributed nationwide and worldwide.

    Product
    Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0303-2026·2026-02-18

    Pro Numb tattoo numbing spray recalled for manufacturing standard violations

    Pro Numb Tattoo Numbing Spray (lot J15) is recalled nationwide due to manufacturing process deviations. The voluntary recall was initiated February 2, 2026.

    Product
    PRO NUMB SENSITIVE SKIN — PRO NUMB SENSITIVE SKIN (NUMBING SPRAY)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2026·2026-02-11

    Olympus Single-Use Sphincterotome V Recalled for Manufacturing Thermoforming Defect

    Olympus Corporation recalls 93 Single-Use 3-Lumen Sphincterotome V devices due to improper thermoforming that may cause deformation and performance loss. Affected devices were distributed nationwide and internationally.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2026·2026-02-11

    Olympus Disposable Sphincterotome Recall for Deformation and Performance Loss

    Olympus Corporation is recalling Disposable Triple Lumen Sphincterotomes (Model KD-401Q-0725) because some units did not undergo proper thermoforming during manufacturing and could deform and lose performance.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2026·2026-02-11

    FDA Recalls 3-Lumen Sphincterotome Devices for Deformation Risk

    Olympus has recalled its Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects. Devices that did not undergo proper thermoforming may deform and lose performance during endoscopic procedures.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2026·2026-02-11

    Olympus Disposable Triple Lumen Sphincterotome Recall Due to Deformation Risk

    Olympus recalls Disposable Triple Lumen Sphincterotomes due to incomplete thermoforming that could cause device deformation and loss of performance. Affected units may not function properly during papillotomy procedures.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2026·2026-02-11

    Olympus Sphincterotome Defective Units Recalled for Potential Device Deformation

    Olympus is recalling CleverCut Single Use 3-Lumen Sphincterotomes (Model KD-V411M-0320) because some units may not have undergone proper thermoforming, potentially causing device deformation and performance loss.

    Product
    Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2026·2026-02-11

    FDA Recalls Single Use Sphincterotome Due to Deformation Risk

    Olympus is recalling Single Use 3-Lumen Sphincterotome V instruments (Model KD-V411M-3020) because some devices may not have undergone proper thermoforming, causing potential deformation and performance loss. The recall affects 650 units.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2026·2026-02-11

    Single Use Sphincterotomes recalled for potential deformation and performance loss

    Olympus Corporation is recalling approximately 2,344 Single Use 3-Lumen Sphincterotome V devices due to manufacturing defects that could cause deformation and loss of surgical performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2026·2026-02-11

    Olympus Sphincterotome Devices Recalled for Deformation and Loss of Performance

    Olympus is recalling over 17,600 3-Lumen Sphincterotome V devices because some units did not undergo proper thermoforming, which could cause them to deform and lose performance.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2026·2026-02-11

    Olympus Sphincterotome Recall: Risk of Device Deformation and Performance Loss

    Olympus is recalling sphincterotomes that did not undergo proper thermoforming, which could cause device deformation and loss of performance. The 5,089 affected units were distributed throughout the US and internationally.

    Product
    Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2026·2026-02-11

    Olympus Disposable Triple Lumen Sphincterotome devices recalled for deformation risk

    Olympus recalls Disposable Triple Lumen Sphincterotome Model KD-401Q-0720 devices due to manufacturing defects that could cause device deformation and loss of performance during medical procedures.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2026·2026-02-11

    Olympus Disposable Triple Lumen Sphincterotome Recall Due to Manufacturing Defect

    Olympus is recalling 887 units of the Disposable Triple Lumen Sphincterotome due to a manufacturing defect. Devices that did not undergo thermoforming could deform and lose performance during use.

    Product
    Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2026·2026-02-04

    Elekta Medical Linear Accelerators Recalled Due to Manufacturing and Electrical Grounding Issue

    Elekta is recalling approximately 5,391 medical linear accelerators (Synergy, Harmony, Infinity, Versa HD models) worldwide due to a manufacturing issue affecting electrical grounding systems.

    Product
    Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1200-2026·2026-02-04

    Medline medical procedure kits recalled for defective adhesive vial tubing

    Medline Industries recalls 117 surgical procedure kits nationwide due to defective MASTISOL adhesive vials. The tubing in the vials cracks during use, potentially affecting surgical procedures.

    Product
    Medline medical procedure convenience kits labeled as: 1) WATKINS SPINE PACK-LF, Kit SKU DYNJ0275635M; 2) SM-SPINE PACK-LF, Kit SKU DYNJ0395037X; 3) TOTAL HIP PACK, Kit SKU DYNJ04809N; 4) MAIN/LAMINECTOMY PACK-LF, Kit SKU DYNJ0565499AN; 5) SCC/SPOC HAND & FOOT PACK, Ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1132-2026·2026-01-28

    Tyber Medical Wrist Plate Recall: Incorrect Thread Orientation

    Tyber Medical is recalling 64 units of VOLT Wrist Treatment System orthopedic plates due to incorrect thread orientation that may affect proper device fixation during surgical repair.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1131-2026·2026-01-28

    VOLT Wrist System Surgical Plate Recalled Due to Incorrect Thread Orientation

    Tyber Medical is recalling a distal radius surgical plate due to incorrect thread orientation in anatomical left plates. This manufacturing defect may affect proper placement or stability of the implant.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1020-2026·2026-01-21

    FreeStyle Libre 3 Sensor Recall Due to Incorrect Glucose Reading Risk

    Abbott recalls approximately 1.06 million FreeStyle Libre 3 sensors due to a manufacturing defect causing carbon buildup that may produce incorrect low glucose readings, potentially affecting diabetes management.

    Product
    FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • SevereFDA (Devices)·Z-1023-2026·2026-01-21

    FreeStyle Libre 3 Plus Sensor Recalled for Incorrect Glucose Readings

    Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors due to a manufacturing defect that may cause carbon buildup, resulting in incorrect low glucose readings.

    Product
    FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1082-2026·2026-01-21

    Bone cement ampoules may fail to break, preventing surgical use

    Heraeus Medical is recalling PALACOS MV+G pro bone cement due to ampoules that may fail to break properly, preventing product use. Affected units were distributed internationally.

    Product
    Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0252-2026·2026-01-14

    ORL Kids Mouthwash recall for manufacturing practice deviations in Arizona

    ORL Kids Mouthwash (bubblegum flavor) is being recalled due to manufacturing process deviations. Signature Formulations, LLC initiated the voluntary recall of approximately 570 bottles distributed in Arizona.

    Product
    ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
    Category
    Drug
    Distribution
    1 state