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.

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 1434

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 MXPGSS
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-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-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 mate
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 throug
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 ma
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 a
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 mater
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 ma
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-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-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-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
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-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-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-0757-2021·2021-01-06
Boston Scientific Recalls Contour VL Ureteral Stents Due to Nickel Debris
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.
Product
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0568-2021·2020-12-23
Galt Medical Recalls Centeze Centesis Catheters Due to Tip Geometry Defect
Galt Medical Corporation is recalling 9,920 Centeze Centesis Catheters because a manufacturing issue resulted in incorrect tip geometry, specifically a thicker wall and more obtuse tip angle.
Product
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0520-2021·2020-12-09
K2M Recalls Yukon Anti-Torque Alignment Tubes Due to Manufacturing Defect
K2M, Inc. is recalling four Yukon Anti-Torque Alignment Tubes from Lot KTGG because shafts do not pass through the inner cannula, potentially delaying surgery.
Product
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0113-2021·2020-12-09
CVS Healing Ointment Recalled for Low Weight Fill Tubes
US Pharmaceuticals is recalling CVS Health Hydrating Healing Ointment due to low weight fill tubes identified in one lot.
Product
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0301-2021·2020-11-04
Smith & Nephew Recalls 5.5MM Arthrogarde Hip Access Cannula
Smith & Nephew is recalling 143 units of 5.5MM Arthrogarde Hip Access Cannulas because the J Lock feature was manufactured incorrectly, preventing proper locking into irrigation extenders or arthroscopes.
Product
5.5MM Arthrogarde Hip Access Cannula
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-0255-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect on the NanoClave may prevent a proper seal with the spike.
Product
148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI:(01)10887709071558(17)250101(30)25(10)4603841. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access fo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0222-2021·2020-10-28
ICU Medical Recalls Intravascular Administration Sets Due to Seal Defect
ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.
Product
123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides acces
Category
Medical Device
Distribution
Distributed nationwide