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.

Which agencies issued them

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.

876–900 of 1441

  • ModerateFDA (Devices)·Z-1501-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Devices)·Z-1473-2021·2021-04-28

    Smiths Medical Recalls LogiCal Left Heart Kits Due to Weld Defects

    Smiths Medical ASD Inc. is recalling specific lots of LogiCal Left Heart Kits and related components due to insufficient or incomplete welds.

    Product
    LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1475-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to potential manufacturing defects in welds.

    Product
    ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1411-2021·2021-04-21

    FDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices

    The FDA is recalling 59,828 units of the Covidien Surgiwand II Suction and Irrigation Device due to a manufacturing defect that generates particulate matter inside the tubing.

    Product
    Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-1152-2021·2021-03-10

    CooperSurgical Recalls Milex Gellhorn Flexible Pessaries Due to Manufacturing Error

    CooperSurgical is recalling specific lots of Milex Gellhorn Flexible pessaries because they were manufactured with incorrect stem lengths.

    Product
    Milex Gellhorn Flexible under the following labels: 1) Gellhorn Flexible w/Short Stem Pessary, REF MXKPGSS2-1/4, 2-1/4" (57 mm) with Kit, 2) Gellhorn Flexible w/Short Stem Pessary, REF MXPGSS2-1/4, 2-1/4" (57 mm) without Kit, 3) Gellhorn Flexible w/Short Stem Pessary, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects

    Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, and foreign material that may compromise barrier protection.

    Product
    Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2021·2021-02-17

    DePuy Universal Femoral Sleeves Recalled for Taper Dimension Issues

    DePuy Orthopaedics is recalling 60 Universal Femoral Sleeves because taper dimensions may be out of specification due to a manufacturing issue.

    Product
    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, or foreign material that may compromise barrier protection.

    Product
    Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2021·2021-02-17

    Cardinal Health Recalls Isolation Gowns Due to Manufacturing Defects

    Cardinal Health is recalling isolation gowns and lab coats due to potential rips, holes, or foreign material that may compromise barrier protection.

    Product
    Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2021·2021-02-17

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.

    Product
    60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential manufacturing defects such as rips, holes, and foreign material.

    Product
    Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1089-2021·2021-02-17

    Cardinal Health Recalls Lab Coats and Gowns Due to Manufacturing Defects

    Cardinal Health is recalling approximately 29.8 million lab coats and isolation gowns due to potential rips, holes, and foreign material that may compromise barrier protection.

    Product
    Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2021·2021-02-17

    ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.

    Product
    7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0813-2021·2021-01-20

    Fresenius Recalls NaturaLyte Liquid Acid Concentrate Bottles

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0831-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below specification.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Conductivity Deviation

    Fresenius Medical Care is recalling Citrasate Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Low Sodium and Calcium Levels

    Fresenius Medical Care is recalling 548 cases of Citrasate Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2021·2021-01-20

    Cook Medical Recalls Disposable Humidification Flasks Due to Stopper Defect

    Cook Medical is recalling 56,250 Disposable Humidification Flasks because a manufacturing defect may cause silicone stoppers to dislodge or gas to leak, impeding gas flow to incubation chambers.

    Product
    Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
    Category
    Medical Device
    Distribution
    Distributed nationwide