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.

426–450 of 1434

ModerateFDA (Drugs)·D-1092-2023·2023-08-30
Helix CBD Therapy Cream Recalled Due to Manufacturing Deviations
Parker Laboratories voluntarily recalled Helix CBD Therapy Cream due to Current Good Manufacturing Practice deviations. The recall affects specific lot numbers distributed nationwide and internationally.
Product
Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-053-01), b) 2 fl. oz. tubes (NDC 30775-053-02), c) 4 fl. oz. tubes (NDC 30775-053-04), Parker Laboratories Inc., Fairfield, NJ, 07004
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2420-2023·2023-08-23
Endoscopic surgical clamp recalled for defective rotation knob
Carefusion 2200 Inc is recalling specific lots of Snowden-Pencer MIS DIAMOND-TOUCH surgical clamps because the rotation knob may crack or break due to a manufacturing defect. Lots B23 and C23 are affected.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7044; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2422-2023·2023-08-23
Endoscopic Surgical Clamp Recalled Due to Potential Rotation Knob Failure
Carefusion is recalling specific lots of Snowden-Pencer MIS endoscopic surgical clamps due to potential cracking or breaking of the rotation knob caused by incorrect adhesive use during manufacturing.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 60 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7046; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2415-2023·2023-08-23
Snowden-Pencer Surgical Grasper Recalled for Cracking Rotation Knob
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer MIS Diamond-Touch Grasper surgical tool due to defects in the rotation knob adhesive that may cause cracking or breaking during use.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2423-2023·2023-08-23
Surgical grasper recalled for rotation knob cracking due to adhesive defect
Carefusion is recalling Snowden-Pencer endoscopic graspers due to potential rotation knob cracking from a manufacturing adhesive defect. Affected lot B23 was distributed in the US and Canada.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER CRILE CURVED JAW 5MM, 32CM, RATCHETED, REF SP90-7048; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2416-2023·2023-08-23
Endoscopic Grasper Instrument Recalled for Rotation Knob Failure Risk
Carefusion 2200 Inc is recalling specific lots of the Snowden-Pencer DIAMOND-TOUCH GRASPER endoscopic surgical instrument due to a manufacturing defect that may cause the rotation knob to crack or break, potentially compromising surgical performance.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2418-2023·2023-08-23
Endoscopic Dissector Surgical Tool Recalled for Cracking Knob Defect
Carefusion 2200 Inc is recalling Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR endoscopic surgical instruments due to potential cracking of the rotation knob from incorrect adhesive use in manufacturing. Lot B23 is affected.
Product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2428-2023·2023-08-23
Endoscopic Surgical Grasper Recalled for Potential Rotation Knob Cracking
Carefusion is recalling specific lots of surgical graspers due to potential cracking of the rotation knob caused by incorrect adhesive use in manufacturing. Affected devices may fail during surgical procedures.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 45CM, RATCHETED HANDLE, REF SP90-7266; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2424-2023·2023-08-23
Endoscopic surgical grasper recalled due to rotation knob defect
Carefusion is recalling specific lots of Snowden-Pencer Diamond-Touch endoscopic graspers due to a manufacturing defect that may cause the rotation knob to crack or break. Affected units were distributed in the US and Canada.
Product
Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM, 32CM, RATCHETED HANDLE, REF SP90-7066; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2419-2023·2023-08-23
Surgical clamp rotation knob may crack or break due to manufacturing defect
Specific lots of Snowden-Pencer surgical clamps may have rotation knobs that crack or break due to incorrect adhesive use in manufacturing. Eight units with lot numbers L22, B23, or C23 distributed in the US and Canada are affected.
Product
Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 25 MM JAW 5MM, 32CM, RATCHETED, REF SP90-7043; endoscopic surgical device
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2288-2023·2023-08-09
TECNIS Symfony Intraocular Lenses Recalled for Unintended Fiducial Marks
Johnson & Johnson is recalling 42 TECNIS Symfony intraocular lenses that may have been manufactured with unintended toric fiducial marks. The lenses are surgical implants used to restore vision.
Product
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2289-2023·2023-08-09
Intraocular Lenses Recalled Due to Unintended Fiducial Marks
Johnson & Johnson is recalling 61 TECNIS Eyhance intraocular lenses that may have been manufactured with unintended toric fiducial marks, which could affect proper surgical positioning. The affected units were distributed to China, India, and Korea.
Product
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-1027-2023·2023-08-09
Cardioplegia Solution Recalled Due to Sterility Assurance Deficiency
Central Admixture Pharmacy Services is recalling 132 bags of Cardioplegia Solution (Lot 36-254403) nationwide due to lack of assurance of sterility and insufficient validation data for decontamination cycles used in the manufacturing process.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, IV Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2023·2023-07-26
RET Distal Probe Recalled Due to Manufacturing Defect in DNA Sequences
FDA recalls RET Distal Probe due to manufacturing defect where DNA sequences used in production were inverted. The defect affects 61 units distributed in California, Florida, Ohio, and South Carolina and may impact diagnostic accuracy.
Product
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2023·2023-07-19
Abiomed Introducer Set Recall Due to Sidearm Detachment Risk
Abiomed 14Fr Low Profile Introducer Sets are being recalled due to silicone oil contamination that may cause sidearm detachment during use. One detachment has been documented; no injuries have been reported.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0922-2023·2023-07-19
Artificial Tears Eye Drops Recalled Due to Manufacturing Facility Contamination
Delsam Pharma's artificial tears eye drops are being recalled nationwide due to confirmed contamination linked to manufacturing facility defects. All affected lots were distributed via two distributors.
Product
Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1%, 1/2 fl oz (15 ml) bottle, Distributed By: Delsam Pharma Llc, Bronx, New York 10467, NDC 72570 121 15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2023·2023-07-19
Medtronic Catalyft LS Spinal Implants Recalled for Out-of-Specification Dimensions
Medtronic recalls 25 units of Catalyft LS spinal implants (lot numbers NM21J039, NM21M026) due to out-of-specification device dimensions that may affect surgical fit and function.
Product
Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, REF 981025522, spinal implant
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0915-2023·2023-07-19
Hand Sanitizer Recalled for Impurities Exceeding Allowable Limits
Big Machine Distillery Hand Sanitizer is being recalled due to manufacturing impurities exceeding allowable limits. No illnesses or injuries have been reported.
Product
Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e)
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-2067-2023·2023-07-12
LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation
Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.
Product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2023·2023-07-12
LinkSymphoKnee Distal Femoral Augment Recalled for Improper Screw Placement
The LinkSymphoKnee Distal Femoral Augment is being recalled because fixation screws were inserted in the wrong direction during manufacturing. The improper placement could affect the implant's structural stability.
Product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2023·2023-07-12
Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect
Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.
Product
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2010-2023·2023-07-05
Limacorporate Prima TT Orthopedic Baseplate Recalled for Manufacturing Defect
Limacorporate is recalling 13 units of the Prima TT Genoid Modular Reverse TT Baseplate due to a manufacturing issue that may cause peripheral holes to be out of specification. Healthcare facilities should contact the manufacturer.
Product
REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0888-2023·2023-07-05
FDA Recalls StellaLife VEGA Oral Care Spray for Manufacturing Practice Violations
The FDA is recalling StellaLife VEGA Oral Care Spray due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide.
Product
StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2009-2023·2023-07-05
Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes
Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2023·2023-07-05
Knee prosthesis femoral segment recalled for specification non-compliance
Waldemar Link is recalling 16 units of a knee prosthesis femoral segment due to specification non-compliance discovered through customer complaints. Patients and healthcare facilities should contact the manufacturer for guidance.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
Category
Medical Device
Distribution
8 states