Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21701–21725 of 50426

HighFDA (Devices)·Z-0421-2021·2020-11-11
3M Red Dot Monitoring Electrode Recall Due to Corrosion Risk
3M is recalling Red Dot Monitoring Electrodes because corrosion could cause performance failures in the ECG monitoring product.
Product
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper box (800 electrodes total).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0378-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-32
Category
Medical Device
Distribution
Distributed nationwide
HighUSDA FSIS·026-2020·2020-11-11
Stuffed Foods LLC Recalls Frozen Mac and Cheese Bites for Undeclared Soy
Stuffed Foods LLC is recalling approximately 1,818 pounds of frozen Mac & Cheese Bites because the product contains soy, an undeclared allergen, and may be misbranded as Buffalo Style Chicken Poppers.
Product
Stuffed Foods LLC — Stuffed Foods LLC Recalls Frozen Snack Products Due to Misbranding and an Undeclared Allergen
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0393-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 53 mm Number: 00-8065-950-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0353-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0397-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 61 mm Number: 00-8065-958-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 acetabular hip cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0420-2021·2020-11-11
3M Recalls Novaplus Monitoring Electrodes Due to Corrosion Risk
3M is recalling Novaplus Monitoring Electrodes because corrosion could cause performance failures. The recall affects 156,600 units distributed worldwide.
Product
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches per shipper box (600 electrodes total).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0400-2021·2020-11-11
Siemens ARTIS Icono X-Ray System Recalled for Software Misalignment
Siemens is recalling ARTIS Icono X-ray systems due to a software defect that may cause inaccurate image overlays, potentially leading to patient danger.
Product
ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2021·2020-11-11
Cardinal Health Recalls MONOJECT Hypodermic Needles Due to Detachment Risk
Cardinal Health is recalling MONOJECT Standard Hypodermic Needles because the needle may detach from the cartridge, posing a risk of needle stick injury.
Product
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0312-2021·2020-11-11
GE Datex-Ohmeda Avance CS2 Anesthesia System Recalled for Damaged Flow Sensors
GE Healthcare is recalling 88 Avance CS2 Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.
Product
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-0329-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-22
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0376-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components
Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0370-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling specific ZCA All Poly Acetabular Cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0323-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 43mm Item Number: 00-8065-540-22 Hip prosthesis component
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0339-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Hip Prosthesis Cups Due to Sterilant Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0310-2021·2020-11-11
Genicon Li-Gator Laparoscopic Clip Applier Recalled for Malfunction
Genicon, Inc. is recalling 8,872 Li-Gator Single Use Laparoscopic Clip Appliers due to device malfunction causing the applier to jam and clip loading failures.
Product
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-26
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0382-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 57 mm Number: 00-8065-654-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2021·2020-11-11
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
Zimmer Biomet is recalling 412 units of ZCA All Poly Acetabular Cups because the hydrogen peroxide sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 49 mm Item Number: 00-8065-546-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0390-2021·2020-11-11
Zimmer Biomet Recalls Acetabular Cup Hip Prosthesis Components
Zimmer Biomet is recalling 412 acetabular cup hip prosthesis components because the sterilant used was not evaluated for biocompatibility, posing a potential risk of adverse tissue reactions.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 00-8065-658-32
Category
Medical Device
Distribution
Distributed nationwide