The Recall Desk

Hazard

Manufacturing Defect recalls

1,434 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,434
Critical
7
Severe
107
Most recent
2026-09-09

Of the 1,434 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 107 (7%) 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.

1151–1175 of 1434

  • HighFDA (Devices)·Z-3071-2017·2017-09-06

    Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.

    Product
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2670-2017·2017-07-12

    Smiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects

    Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.

    Product
    Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2624-2017·2017-07-05

    Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2625-2017·2017-07-05

    Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0924-2017·2017-07-05

    Apothecary by Design Recalls Progesterone Injection Vials Due to Closure Defect

    Apothecary by Design is recalling 25 vials of Progesterone Injection in Olive Oil due to a manufacturing defect where metal closures may adhere to rubber stoppers, potentially compromising container integrity.

    Product
    Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2017·2017-06-07

    Philips NMT Patient Cable Recall for Potential Skin Burn Risk

    Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.

    Product
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
    Category
    Medical Device
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-2120-2017·2017-05-31

    Bard StatLock IV Premium Catheter Stabilization Device Recalled for Sizing Error

    Bard Access Systems is recalling 4,500 units of StatLock IV Premium Catheter Stabilization Devices because they may contain incorrectly sized retainer clips.

    Product
    StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 devices and cases containing 250 devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1766-2017·2017-04-19

    Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Valve Seal Defect

    Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.

    Product
    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1412-2017·2017-03-15

    Encore Medical Recalls Turon Impaction Fixtures Due to Material Wear

    Encore Medical is recalling 297 Turon Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

    Product
    Turon Impaction Fixture
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0502-2017·2017-03-08

    Sun Pharmaceutical Recalls Alfuzosin Hydrochloride Tablets Due to Foreign Matter

    Sun Pharmaceutical Industries is recalling specific lots of Alfuzosin Hydrochloride Extended-release Tablets because a consumer complaint identified a broken piece of wire rope embedded in a tablet.

    Product
    ALFUZOSIN HYDROCHLORIDE — ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2017·2017-02-22

    BD Vacutainer Blood Collection Tubes Recalled for Excess Anticoagulant

    Becton Dickinson is recalling specific lots of BD Vacutainer blood collection tubes because they contain approximately twice the expected amount of buffered sodium citrate additive.

    Product
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2017·2017-02-15

    AngioDynamics Recalls Celerity ECG Cable Accessory Packs Due to Soldering Defect

    AngioDynamics is recalling Celerity ECG Cable Accessory Packs because the ECG clip cable may not be soldered correctly, potentially preventing the device from conducting ECG signals.

    Product
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0467-2017·2017-02-08

    VistaPharm Recalls Methadone Hydrochloride Oral Concentrate Due to Water Contamination

    VistaPharm is recalling 3,354 bottles of Methadone Hydrochloride Oral Concentrate because the purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2017·2017-02-01

    INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration

    INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.

    Product
    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1057-2017·2017-02-01

    On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects

    On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.

    Product
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repa
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0826-2017·2016-12-28

    Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect

    Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.

    Product
    Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0669-2017·2016-12-07

    Terumo Recalls MISAGO RX Self Expanding Peripheral Stent

    Terumo Medical Corp is recalling 7,965 MISAGO RX Self Expanding Peripheral Stents nationwide because they do not conform to product specifications regarding diameter and shape.

    Product
    MISAGO RX Self Expanding Peripheral Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0168-2017·2016-12-07

    Nationwide Laboratories Recalls Phenazopyridine Hydrochloride Tablets Due to CGMP Deviations

    Nationwide Laboratories LLC is recalling Phenazopyridine Hydrochloride Tablets, 200 mg, due to manufacturing deviations that may result in assay or content uniformity failures.

    Product
    Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0336-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0342-2017·2016-11-09

    Stryker Neurovascular Recalls Guider Softip XF Guide Catheters

    Stryker Neurovascular is recalling 1,478 Guider Softip XF guide catheters due to a manufacturing defect that could cause hub leaks.

    Product
    Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
    Category
    Medical Device
    Distribution
    3 states