Hazard

Manufacturing Defect recalls

917 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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.

401–425 of 917

ModerateFDA (Drugs)·D-0465-2024·2024-05-01
FUL-GLO Fluorescein Sodium Ophthalmic Strips Recalled for API Manufacturing Defect
Nomax Inc recalls FUL-GLO Fluorescein Sodium Ophthalmic Strips (Lot 14776) nationwide due to API manufacturing specification failures. The active ingredient was not manufactured to current USP standards regarding unspecified impurities.
Product
FUL-GLO, Fluorescein Sodium Ophthalmic Strips USP 1 mg, 100 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-404-01.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0438-2024·2024-04-17
FDA Recalls Lansoprazole Delayed-Release Capsules for Manufacturing Practice Deviations
NATCO Pharma Limited is voluntarily recalling 30 bottles of Lansoprazole 15 mg delayed-release capsules due to Current Good Manufacturing Practice deviations. The product was distributed nationwide in the United States.
Product
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1476-2024·2024-04-10
Abbott ARCHITECT STAT Myoglobin Reagent Kit recalled due to manufacturing defect
Abbott is recalling certain myoglobin test kits because of manufacturing defects that could lead to incorrect results and delayed heart attack diagnosis.
Product
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1392-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1459-2024·2024-04-10
Medline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
Product
Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2024·2024-04-10
Medline Pediatric Magill Catheter Recalled for Weak Seal Risk
Medline is recalling its Centurion FCP Magill Catheter (7.5 in. pediatric) because the product may have a weak seal that could compromise sterility. The affected units were distributed in the US, Panama, and Canada.
Product
Centurion FCP MAGILL CATH 7.5 IN PED (67575), Product Code 67575
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1393-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall
X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.
Product
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1399-2024·2024-04-10
BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement
Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.
Product
BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1302-2024·2024-04-03
Boston Scientific steerable sheath devices recalled due to manufacturing defect risk
Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1396-2024·2024-04-03
Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect
Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1340-2024·2024-03-27
Vascular Guidewire Introducer Recalled Due to Internal Hub Defect
A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.
Product
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2024·2024-03-27
Dental Implant Impression Coping Recalled for Manufacturing Defect
Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.
Product
impression coping, repositionable, short, screw-retained, PF 4.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2024·2024-03-27
Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect
Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2024·2024-03-27
Surgical Guidewire Introducer Sheath Recalled for Internal Manufacturing Defects
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2024·2024-03-27
Vascular guidewire introducer recalled for manufacturing defect
Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.
Product
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1321-2024·2024-03-27
Preat Nobel RP Titanium Abutment Blank Recalled for Manufacturing Defect
Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.
Product
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2024·2024-03-27
Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function
Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2024·2024-03-27
MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures
Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2024·2024-03-27
Guidewire Introducer Sheath Recalled for Internal Lumen Voids
Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.
Product
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2024·2024-03-27
Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect
Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.
Product
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1335-2024·2024-03-27
Angiodynamics Guidewire Introducer Devices Recalled for Manufacturing Defects
Angiodynamics recalls MINI STICK MAX guidewire introducer devices due to manufacturing defects in the internal lumen that may prevent guidewire passage and delay surgical procedures.
Product
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1339-2024·2024-03-27
Angiodynamics surgical guidewire recalled for manufacturing defect
Angiodynamics is recalling 5,176 units of MINI STICK MAX guidewires due to manufacturing voids that prevent passage through the introducer during surgery. Surgeons may need to exchange the sheath to complete procedures.
Product
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1346-2024·2024-03-27
Guidewire Introducer Sheath from Angiodynamics Recalled for Manufacturing Defect
Angiodynamics is recalling 65 units of its MINI STICK MAX guidewire introducer sheath due to manufacturing defects that may prevent guidewires from passing through during surgical procedures.
Product
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1344-2024·2024-03-27
Guidewire Introducer Sheath with Manufacturing Defect Recalled by Angiodynamics
Angiodynamics is recalling MINI STICK MAX guidewire introducer sheaths due to manufacturing defects that may prevent guidewire passage. The defect may cause procedural delays requiring equipment exchange during vascular interventions.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1336-2024·2024-03-27
FDA Recalls Vascular Guidewire Introducer Due to Manufacturing Defect
Angiodynamics is recalling 959 units of MINI STICK MAX guidewire introducers due to voids in the sheath hub that may prevent proper guidewire placement. Users may experience procedure delays and need to exchange equipment.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751
Category
Medical Device
Distribution
Distributed nationwide