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.

326–350 of 917

  • SevereFDA (Devices)·Z-2590-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2589-2024·2024-09-04

    Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk

    Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2597-2024·2024-09-04

    PORTEX Bivona Tracheostomy Tube Securement Flange May Tear Due to Manufacturing Defect

    Smiths Medical recalls specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, potentially affecting tube positioning.

    Product
    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2941-2024·2024-09-04

    FRT250 Telescopic Implant Cartridge Recalled for Component Substitution

    OrthoPediatrics Canada is recalling FRT250 cartridges used in the Fassier-Duval Telescopic IM System because an incorrect component was substituted during assembly.

    Product
    FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2614-2024·2024-09-04

    Pediatric Tracheostomy Tubes Recalled Due to Defective Securement Flange

    Smiths Medical recalls pediatric tracheostomy tubes from specific lots due to a manufacturing defect that may cause the securement flange to tear. No injuries have been reported.

    Product
    a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRA
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2819-2024·2024-09-04

    Beaver Visitec Recalls Medical Device Syringes in CustomEyes Procedure Packs

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs because they contain defective syringes manufactured by Sol-M. The 237 affected units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000711;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2832-2024·2024-09-04

    Voluntary Recall of BVI CustomEyes Procedure Packs With Sol-M Syringes

    BVI voluntarily recalls CustomEyes Procedure Packs because they contain syringes recalled by their manufacturer, Sol-Millennium Medical, Inc. Approximately 94 units were distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000910;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2912-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled Due to Sol-M Syringe Components

    Beaver Visitec recalls BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes subject to manufacturing defect concerns. 17 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001774;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2844-2024·2024-09-04

    BVI CustomEyes Procedure Packs Containing Sol-M Syringes Recalled Nationwide

    Beaver Visitec International is recalling 880 units of BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-M, Inc., distributed nationwide in the United States.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001113;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2885-2024·2024-09-04

    BVI CustomEyes Procedure Packs recalled due to Sol-M syringes

    BVI CustomEyes Procedure Packs containing Sol-M syringes are being recalled due to a voluntary manufacturer recall of the syringe components included in these procedure packs.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2024·2024-08-28

    Barricaid Annular Closure Impactor recalled due to missing welds

    Intrinsic Therapeutics recalls 207 units of Barricaid Annular Closure Impactor devices nationwide due to manufacturing defects where at least two units are missing critical welds.

    Product
    Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2687-2024·2024-08-28

    Dental Digital Analog Products Recalled for Out-of-Specification Rotation

    Preat Corp is recalling 185 dental digital analog products due to out-of-specification rotation affecting inspection accuracy. The devices are used in dental laboratories for visual inspection of abutments and restorations.

    Product
    Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2024·2024-07-24

    Autotome RX Cannulating Sphincterotome Recalled for Potential Device Malfunction

    Boston Scientific recalls the Autotome RX Cannulating Sphincterotome due to foreign material on the cutting wire that may prevent proper device function and extend procedure time. No injuries reported.

    Product
    Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2024·2024-07-17

    Decompression Table Model E9011 Recalled for Structural Frame Defect

    Pivotal Health Solutions is recalling 32 Decompression Table Model E9011 devices due to potentially insufficient rework on a lumbar frame part. The defect affects units distributed to CA, FL, TX, ID, GA, and TN.

    Product
    Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2234-2024·2024-07-10

    Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect

    SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2024·2024-07-10

    FDA recalls Dream Cream topical product due to manufacturing quality violations

    Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.

    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2024·2024-07-10

    Drug Recall: Little Moon Essentials Magical Muscle Oil due to CGMP Deviations

    Little Moon Essentials is recalling Magical Muscle Oil due to manufacturing practice deviations. The recall affects 1,654 glass jars distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0575-2024·2024-07-10

    FDA Recalls Little Moon Essentials Vital Vapor Balm Due to Manufacturing Deviations

    Little Moon Essentials has voluntarily recalled Vital Vapor Balm (camphor 0.6%, menthol 5.2%) due to Current Good Manufacturing Practice deviations. The Class II recall affects 1,041 units distributed nationwide in the United States and Canada.

    Product
    Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 7072
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0573-2024·2024-07-10

    Drug Recall: Little Moon Essentials Aching Head Rub for Manufacturing Defects

    Little Moon Essentials Aching Head Rub is being recalled by the manufacturer for manufacturing deviations. The voluntary recall affects 6,312 units distributed nationwide and in Ontario, Canada.

    Product
    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0577-2024·2024-07-10

    Little Moon Essentials Asana Kisser Drug Recalled Due to CGMP Deviations

    Little Moon Essentials Asana Kisser, a topical product containing camphor and menthol, is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 320 units distributed in the United States and Canada.

    Product
    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0578-2024·2024-07-10

    Hand Sanitizer Recalled for Manufacturing Practice Violations

    Little Moon Essentials Clear Breeze Plus Hand Sanitizer is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2159-2024·2024-07-03

    Inspire Model 3028 Implantable Pulse Generator Manufacturing Defect

    Inspire Medical Systems recalls the Model 3028 Implantable Pulse Generator due to a manufacturing defect causing electrical leakage and system malfunction that requires revision surgery. The recall affects 24 devices distributed in the US and Germany.

    Product
    Inspire Model 3028, IV Implantable Pulse Generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2208-2024·2024-07-03

    Medtronic COBALT VR MRI SureScan implantable defibrillators recalled for manufacturing defect

    Medtronic is recalling 4 COBALT VR MRI SureScan implantable cardioverter defibrillators due to a manufacturing defect involving a weld crack identified during quality control testing.

    Product
    COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2024·2024-07-03

    Medtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect

    Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.

    Product
    CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide