The Recall Desk

Hazard

Defect recalls

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

What the numbers show

Total
20
Critical
1
Severe
0
Most recent
2026-04-29

Of the 20 defect recalls we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 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.

1–20 of 20

  • ModerateFDA (Devices)·Z-1903-2026·2026-04-29

    OER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide

    Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.

    Product
    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2024·2024-09-04

    Medline Medical Procedural Kits Recalled for Defective Plastic Syringes

    Multiple Medline procedural kits contain defective plastic syringes that may leak or break during medical procedures. The FDA has advised of potential patient health risks from these manufacturing quality issues.

    Product
    Medline procedural kits labeled as: 1) GLMI ARTHROGRAM KIT:PCL, Pack Number SPEC0300B; 2) MERCY MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 3) NURSERY CIRCUMCISION TRAY, Pack Number CIT4845; 4) PERIPHERAL ULTRASOUND CATHETER INSERTION, Pack Number MNS9865; 5) STERI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2773-2024·2024-09-04

    Medical convenience kits with syringes recalled due to quality issues

    Medline Industries is recalling Centurion procedure packs containing plastic syringes affected by an FDA Safety Alert from March 19, 2024. The syringes may have leaks, breakage, or other quality issues that could pose a health risk.

    Product
    Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580;
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2840-2024·2024-09-04

    BVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Issue

    Beaver Visitec International is voluntarily recalling BVI CustomEyes Procedure Packs containing syringes manufactured by Sol-Millennium Medical, which are subject to a separate voluntary recall.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001048;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2842-2024·2024-09-04

    BVI CustomEyes Procedure Packs with Sol-M Syringes Recalled

    BVI CustomEyes Procedure Packs containing Sol-M manufactured syringes are subject to a voluntary recall. The recall affects 9 units distributed nationwide.

    Product
    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001073;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2442-2024·2024-08-14

    Medline Medical Procedure Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling over 1.6 million medical procedure kits nationwide and internationally due to plastic syringe defects. The affected kits contain syringes with leaks, breakage, and quality issues that may pose risks to patient health.

    Product
    Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack Number DYNJRA1268C; 3) WAL- UNIVERSAL BLOCK TRAY, Pack Number DYNJRA1638C; 4) BASIC DIAGNOSTIC TRAY, Pack Number DYNJRA1928; 5) PREOP NERVE BLOCK TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2023·2022-11-30

    Surgical convenience kits containing recalled 3M surgical drapes

    ROi CPS LLC recalled surgical convenience kits because they contained 3M surgical drapes that were recalled. The specific defect is not described.

    Product
    regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2459-2020·2020-07-08

    LivaNova Recalls 220 Units of 3/8 Inch Y Connectors

    LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.

    Product
    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
    Category
    Medical Device
    Distribution
    44 states
  • ModerateFDA (Devices)·Z-2706-2017·2017-07-19

    Fujifilm Recalls Ultrasonic Endoscope Model EG-530UT

    Fujifilm Medical Systems is recalling four units of the EG-530UT ultrasonic endoscope following a retrospective review.

    Product
    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2244-2017·2017-06-14

    ConvaTec Recalls Adult Non-Rebreather Masks Due to Defect

    ConvaTec, Inc. is voluntarily recalling adult non-rebreather masks with 'No-Crush' tubing. The recall was initiated in May 2017 and is now terminated.

    Product
    Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2239-2017·2017-06-14

    ConvaTec Recalls Pediatric Oxygen Masks Due to Potential Defect

    ConvaTec is voluntarily recalling specific lots of pediatric oxygen masks. The recall addresses a potential defect in the high-concentration rebreather devices.

    Product
    Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1290-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.

    Product
    Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1286-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

    Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

    Product
    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1292-2016·2016-04-06

    Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1293-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Back Support Suspenders

    Ossur Americas is recalling various medical devices, including back support suspenders, due to a defect described in the source text.

    Product
    Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1298-2016·2016-04-06

    Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

    Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

    Product
    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to secure
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1289-2016·2016-04-06

    Ossur Recalls Rebound Cartilage Knee Braces and Other Medical Devices

    Ossur Americas is recalling Rebound Cartilage knee braces and other medical devices due to a defect described in the source text.

    Product
    Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-0039-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Wound Therapy Canisters

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters due to visible deformation of the inlet port on the canister lid.

    Product
    RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2015·2014-10-15

    Smith & Nephew Recalls RENASYS EZ Canisters Due to Deformation

    Smith & Nephew is recalling RENASYS EZ and RENASYS EZ Plus canisters because the inlet port on the lid may be deformed.

    Product
    RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1804-2012·2012-06-20

    Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits

    Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary recall of VY Flush Heparin Lock Flush Syringes.

    Product
    Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
    Category
    Medical Device
    Distribution
    Distributed nationwide