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.

776–800 of 1441

HighFDA (Devices)·Z-0367-2022·2021-12-22
MENTOR Saline-Filled Breast Implants Recalled for Deflation Risk
Mentor Texas is recalling 28,348 MENTOR Saline-Filled Breast Implants due to a manufacturing defect that may cause a weakened base patch, potentially leading to implant leakage or deflation.
Product
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0283-2022·2021-12-22
Methylcobalamin Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated, dba Cape Drugs, is recalling Methylcobalamin 12mg/ml injection (Lot #188008) due to lack of processing controls. The recall affects 27 vials distributed in Maryland.
Product
Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0279-2022·2021-12-22
Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0284-2022·2021-12-22
B-Complex Injection Recalled Due to Lack of Processing Controls
Valgene Incorporated dba Cape Drugs is recalling B-Complex injection in 1 mL vials (Lot# 190036, BUD 12/27/2021) distributed in Maryland due to lack of processing controls.
Product
B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409
Category
Drug
Distribution
1 state
CriticalFDA (Devices)·Z-0344-2022·2021-12-15
Puritan Bennett 980 Series Ventilators Recalled for Incorrect Capacitor Assembly
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0339-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect
Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.
Product
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0352-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error
Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.
Product
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0347-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect
Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0340-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect
Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.
Product
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0345-2022·2021-12-15
Puritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error
Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.
Product
Puritan Bennett 980 Series Ventilator,980X1ENAIQC
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0338-2022·2021-12-15
Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error
The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.
Product
Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0348-2022·2021-12-15
Puritan Bennett 980 Ventilator recalled for capacitor assembly defect
The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.
Product
Puritan Bennett 980 Series Ventilator, 980X1ENNISB
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0351-2022·2021-12-15
Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.
Product
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0270-2022·2021-12-15
Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.
Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152…
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·21V936000·2021-12-01
Kia Rio 2020–2021 brake master cylinder defect recall
Kia Motors recalls 2020–2021 Rio vehicles due to brake master cylinder manufacturing defects that can reduce braking performance. The defect may cause longer pedal travel and extended stopping distance, increasing crash risk.
Product
KIA — KIA RIO
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0244-2022·2021-11-24
Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination
Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.
Product
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0237-2022·2021-11-24
LOTRIMIN AF Jock Itch Powder Spray Recalled for Benzene Contamination
Bayer Healthcare is recalling LOTRIMIN AF Jock Itch Powder Spray (Miconazole nitrate 2%, 4.6 OZ cans) distributed nationwide due to manufacturing facility cGMP deviations where other lots were found to be contaminated with benzene.
Product
LOTRIMIN AF (Miconazole nitrate 2%) Jock Itch Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0237-2022·2021-11-24
Hip implant stem missing surface treatment affecting seven units
OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.
Product
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Category
Medical Device
Distribution
2 states
HighFDA (Drugs)·D-0239-2022·2021-11-24
Lotrimin Daily Prevention Deo recalled for potential benzene contamination
Bayer Healthcare Pharmaceuticals is recalling Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray due to potential benzene contamination. The product was manufactured at a facility where other lots were found contaminated with benzene.
Product
LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0231-2022·2021-11-17
Tadalafil Tablets Recalled Due to Incorrect Product Formulation
Sun Pharmaceutical is recalling Tadalafil Tablets USP 20 mg due to use of an incorrect grade of Crospovidone during manufacturing. The recall affects 36,786 bottles distributed to one distributor.
Product
TADALAFIL — TADALAFIL (TADALAFIL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0228-2022·2021-11-17
Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin 10 mg/80 mg tablets because the product was manufactured using an excipient that failed conductivity specifications.
Product
EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Category
Drug
Distribution
2 states
SevereFDA (Drugs)·D-0087-2022·2021-11-10
Irbesartan Tablets Recalled for Impurity in Active Ingredient
Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2022·2021-11-10
Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band
Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.
Product
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-0176-2022·2021-11-03
ASC PneumoLiner surgical device recalled due to manufacturing orientation defect
Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.
Product
ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0079-2022·2021-11-03
Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide