Hazard

Molding Defect recalls

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

What the numbers show

Total: 23
Critical: 0
Severe: 0
Most recent: 2025-01-22

Of the 23 molding defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all molding 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.

1–23 of 23

HighFDA (Devices)·Z-0835-2025·2025-01-22
Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk
Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.
Product
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1543-2024·2024-04-24
Smiths Medical Medfusion Pump Guide Barrel Clamp Molding Defect Recall
Smiths Medical is recalling Medfusion Guide Barrel Clamps due to a molding defect that could cause spring slippage, preventing the pump from recognizing or correctly identifying loaded syringes.
Product
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1542-2024·2024-04-24
Smiths Medical syringe pumps recalled for molding defect in barrel clamp guide
Smiths Medical is recalling certain Model 3010 syringe pumps due to a molding defect in the barrel clamp guide that may prevent proper syringe recognition. Affected units were manufactured or serviced between July 2016 and April 2021.
Product
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1541-2024·2024-04-24
Smiths Medical Medfusion syringe pumps may fail to recognize syringes
Smiths Medical syringe pumps with defective barrel clamp guides may fail to recognize or correctly identify loaded syringes, potentially affecting medication delivery accuracy.
Product
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2468-2023·2023-09-06
Chevalier Valvulotome Surgical Instrument Recalled Due to Burr Defect
LeMaitre Vascular is recalling certain Chevalier Valvulotome surgical instruments used in vein-graft procedures due to burrs on the cutting tip that may tear the harvested vein. The recall affects 225 units distributed internationally.
Product
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an invert
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1568-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect
ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.
Product
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1583-2021·2021-05-19
ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect
ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1579-2021·2021-05-19
ICU Medical Recalls Sprios Male Luer Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1573-2021·2021-05-19
ICU Medical Recalls Oncology Kits Due to Molding Defect
ICU Medical is recalling specific lots of Oncology Kits with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.
Product
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1566-2021·2021-05-19
ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage
ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1585-2021·2021-05-19
ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect
ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.
Product
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1571-2021·2021-05-19
ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.
Product
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the admi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1589-2021·2021-05-19
ICU Medical Recalls IV Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of IV administration sets because a molding defect may cause leakage in the inactivated position.
Product
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1570-2021·2021-05-19
ICU Medical Recalls Sprios Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.
Product
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or cathe
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1565-2021·2021-05-19
ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage
ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1577-2021·2021-05-19
ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect
ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.
Product
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1587-2021·2021-05-19
ICU Medical Recalls Bag Spike Adapters Due to Molding Defect
ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1576-2021·2021-05-19
ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect
ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.
Product
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1575-2021·2021-05-19
ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect
ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.
Product
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administ
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1588-2021·2021-05-19
ICU Medical Recalls Spiros Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of leakage in the inactivated position.
Product
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0649-2017·2016-11-30
Merit Medical Recalls Fluid Administration Sets Due to Molding Defect
Merit Medical Systems is voluntarily recalling 107,341 Fluid Administration Sets due to a molding defect in the drip chamber.
Product
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2012·2012-08-08
ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect
ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.
Product
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2128-2012·2012-08-08
ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect
ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.
Product
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
Category
Medical Device
Distribution
Distributed nationwide