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.

551–575 of 1434

HighFDA (Devices)·Z-0228-2023·2022-11-23
TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties
LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.
Product
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0065-2023·2022-11-23
Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls
Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.
Product
PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0222-2023·2022-11-16
X-Guide X-Mark Probe Tool Recall: Missing Weld Creates Aspiration Risk
X-NAV Technologies is recalling the X-Guide X-Mark Probe Tool because a critical weld may be missing, potentially allowing the probe tip to detach and fall into a patient's mouth during use, creating a risk of aspiration or swallowing.
Product
X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0196-2023·2022-11-16
Alphatec Spine Disc Preparation Instruments Recalled for Regulatory Non-Compliance
Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.
Product
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-1105
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0170-2023·2022-11-09
Aneurysm Embolization System Detachment Controller Recalled for Manufacturing Defect
MICROVENTION is recalling WEB Detachment Controllers due to an out-of-specification tunnel opening that may prevent proper implant detachment. This defect could delay treatment and cause vessel damage from implant manipulation.
Product
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0040-2023·2022-11-09
Moxifloxacin Preservative-Free Eye Drops Recalled for Sterility Assurance Failure
Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Product
MOXIFLOXACIN PRESERVATIVE FREE SYR, 0.15 mg/0.1 mL, Sterile Solution, 1 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
ModerateFDA (Drugs)·D-0025-2023·2022-11-09
Ranibizumab eye implant recalled for non-functioning delivery system
Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.
Product
SUSVIMO — SUSVIMO (RANIBIZUMAB)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2023·2022-11-02
Stryker INBONE Tibial Tray Recalled Due to Oversized Lock Detail
Stryker INBONE Tibial Trays are being recalled due to an oversized lock detail that could affect proper component assembly and implant function. Affected units were distributed in New York.
Product
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2023·2022-11-02
GORE CARDIOFORM ASD Occluder Cardiovascular Implants Recalled for Manufacturing Test Failure
W L Gore & Associates is recalling 98 GORE CARDIOFORM ASD Occluder cardiovascular implants due to failed manufacturing release test results. Affected units were distributed nationwide and internationally.
Product
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0021-2023·2022-11-02
Quinapril and Hydrochlorothiazide Tablets Recalled Due to Manufacturing Impurity
Aurobindo Pharma USA Inc. is recalling Quinapril/Hydrochlorothiazide Tablets 20mg/12.5mg due to N-nitroso-quinapril impurity above acceptable limits from manufacturing deviations. Affected lots QE2021005-A and QE2021010-A were distributed nationwide.
Product
QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE — QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE (QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0016-2023·2022-11-02
Proton Armor hand sanitizer recalled for methanol contamination
Ultra Chem Labs Corp is recalling Proton Armor hand sanitizer nationwide due to trace amounts of methanol found in a manufacturing component. No illnesses have been reported.
Product
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details:
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2023·2022-11-02
Stryker INBONE Tibial Tray recalled for oversized lock detail defect
Wright Medical Technology is recalling one Stryker INBONE Tibial Tray due to an oversized tibial tray lock detail that exceeds product specifications and could affect device functionality.
Product
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0108-2023·2022-10-26
Medicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material
Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.
Product
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0086-2023·2022-10-19
Veritas Advanced Infusion Packs Recalled for Broken Irrigation Luer
Johnson & Johnson Surgical Vision is recalling 53,624 units of Veritas Advanced Infusion Packs due to manufacturing defects causing broken or cracked irrigation luers that could compromise ophthalmic surgical procedures.
Product
Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Category
Medical Device
Distribution
25 states
HighFDA (Drugs)·D-1543-2022·2022-10-05
FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content
Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.
Product
NEORAL — NEORAL (CYCLOSPORINE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1775-2022·2022-09-28
Puritan Bennett 560 Ventilator Recalled for Loss of Gas Supply
Covidien is recalling the Puritan Bennett 560 Ventilator due to a manufacturing error in turbine components that causes loss of gas supply and device inoperability. Six incidents have been confirmed from customers outside the United States.
Product
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1724-2022·2022-09-21
ICU Medical Trifuse Extension Set Recalled for Connector Housing Gap
ICU Medical is recalling 5.8 million Trifuse Extension Sets due to a manufacturing defect that creates a visible gap between the connector's housing parts. The gap could lead to disconnection or fluid leakage during infusion.
Product
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1719-2022·2022-09-21
Medical connector recalled due to manufacturing housing gap defect
ICU Medical is recalling MicroClave Clear Neutral Connectors used in intravascular catheters due to a manufacturing defect that creates a visible gap between housing parts.
Product
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1723-2022·2022-09-21
ICU Medical IV Connector Extension Set Recalled for Manufacturing Defect
ICU Medical is recalling intravascular administration set connectors due to a manufacturing defect that creates a visible gap in the connector housing. The defect affects approximately 5.8 million units distributed nationwide and internationally.
Product
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1720-2022·2022-09-21
ICU Medical Infusion Extension Set Recall Due to Connector Housing Gap
ICU Medical recalls 5.8 million infusion extension sets due to a manufacturing defect that creates a visible gap in the connector housing, potentially compromising device integrity.
Product
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Category
Medical Device
Distribution
53 states
HighFDA (Drugs)·D-1537-2022·2022-09-21
Hand Sanitizer Recalled for Manufacturing Defects and Chemical Impurities
Superior Glove Works is recalling Synergy Hand Sanitizer due to acetaldehyde impurity and excess total impurities above specification limits. The 80% alcohol topical antiseptic was distributed nationwide.
Product
Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy S
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2022·2022-09-21
Extension Set Recall Due to Connector Housing Manufacturing Defect
ICU Medical is recalling bifurcated extension sets used in medical infusions. The sets have a manufacturing defect causing visible gaps in the connector housing, affecting millions of units distributed in the U.S. and internationally.
Product
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Category
Medical Device
Distribution
53 states
ModerateFDA (Drugs)·D-1535-2022·2022-09-21
Triamcinolone Acetonide Cream Recalled Due to Manufacturing Quality Defects
Direct Rx is recalling Triamcinolone Acetonide cream 0.1% due to manufacturing quality deviations that resulted in gritty texture and lack of effectiveness. The affected lot is 12JY2216, expiring February 29, 2024.
Product
TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE CREAM)
Category
Drug
Distribution
2 states
ModerateFDA (Drugs)·D-1513-2022·2022-09-21
Magnesium Citrate Saline Laxative Recalled for Manufacturing Deviations
Vi-Jon, LLC voluntarily recalled Magnesium Citrate Saline Laxative due to manufacturing process deviations. Over 8 million units of the product were distributed nationwide.
Product
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 66220 4 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; b) CVS Health UPC 0 50428 30745 8 Distributed by: CVS Pharmacy,
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1654-2022·2022-09-14
Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing
Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.
Product
Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Category
Medical Device
Distribution
42 states