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.

6501–6525 of 52962

HighFDA (Devices)·Z-0362-2025·2024-11-20
IMAGEnet 6 Ophthalmic Data System Hood Report Display Issue
IMAGEnet 6 ophthalmic software's Hood Report overlay can mislead clinicians about clinical correlations unsupported by evidence. Affects 3,144 units nationwide.
Product
The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0453-2025·2024-11-20
Halyard Pacemaker Tray Surgical Kits Recalled for Loose Metal Flakes
AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.
Product
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0415-2025·2024-11-20
Halyard ORTHO PACK surgical instrument kits recalled due to metal flakes
AVID Medical is recalling Halyard ORTHO PACK kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2025·2024-11-20
UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling
MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.
Product
UA KIT, SKU DYKM1690A; Component No. 503581
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0446-2025·2024-11-20
Halyard EP TRAY Surgical Kits Recalled for Loose Metal Flakes
AVID Medical is recalling Halyard EP TRAY surgical convenience kits due to sponge forceps and towel clamps that may shed small metal flakes. These flakes could enter surgical sites, potentially causing local or foreign body reactions.
Product
Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V875000·2024-11-20
Volkswagen ID.4 rearview camera image may not display in reverse
Volkswagen is recalling certain 2023 ID.4 vehicles because the rearview camera image may not display when the vehicle is placed in reverse, failing FMVSS 111.
Product
VOLKSWAGEN — VOLKSWAGEN ID.4
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2025·2024-11-20
IV Bag Containers Recalled for Leaking During Filling Process
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
Product
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0368-2025·2024-11-20
Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0429-2025·2024-11-20
AVID Medical Recalls Pacemaker Convenience Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard SAMMC-N pacemaker convenience kits because sponge forceps and towel clamps may shed metal flakes that could enter a patient's surgical site.
Product
Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2025·2024-11-20
AVID Medical Recalls Heart Cath Lab Kits Due to Metal Flakes
AVID Medical is recalling 411 Heart Cath Lab Kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number: MSBM003-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0341-2025·2024-11-20
Metrix SECURE 1000 mL IV Container Recall Due to Leaking
The Metrix Company is recalling SECURE 1000 mL empty IV containers because a limited number were found to leak during filling.
Product
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0372-2025·2024-11-20
Medtronic Recharger Kits Recalled for Potential Failure to Initiate Recharging
Medtronic is recalling 118 wireless recharger kits for implantable neurostimulators because they may fail to start a recharging session upon first use.
Product
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Bra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0411-2025·2024-11-20
AVID Medical Recalls Halyard Line Insertion Packs Due to Metal Flakes
AVID Medical is recalling Halyard Line Insertion Packs because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2025·2024-11-20
Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes
AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.
Product
Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0132-2025·2024-11-20
Frozen Potato Wedges Recalled for Undeclared Wheat Allergen
JR Simplot's frozen seasoned potato wedges are being recalled because the product contains wheat but the label does not declare this allergen. The affected product was distributed to retailers in Pennsylvania only.
Product
Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES, VEGE
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0432-2025·2024-11-20
AVID Medical Recalls Halyard CPT PEDS ADULT CH PACK Surgical Kits
AVID Medical is recalling 81 units of Halyard CPT PEDS ADULT CH PACK surgical kits because sponge forceps and towel clamps may shed metal flakes.
Product
Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0439-2025·2024-11-20
AVID Medical Recalls Halyard EP PACK Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard EP PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard EP PACK - Medical convenience kits Model Number: VANW018-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0445-2025·2024-11-20
AVID Medical Recalls Halyard Surgical Kits Due to Metal Flakes
AVID Medical is recalling Halyard SPECIALS PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
Product
Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0403-2025·2024-11-20
AVID Medical Recalls Halyard MINOR PDS Medical Convenience Kits
AVID Medical, Inc. is recalling 137 Halyard MINOR PDS medical convenience kits because sponge forceps and towel clamps may release metal flakes into surgical sites.
Product
Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2025·2024-11-20
Olympus UroPass Ureteral Access Sheaths recalled for UV-induced brittleness
Olympus is recalling UroPass Ureteral Access Sheaths because ultraviolet radiation exposure can cause the dilator tip to become brittle and break during surgery or in storage. Approximately 14,093 units have been distributed worldwide.
Product
Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0414-2025·2024-11-20
Halyard Surgical Kit Components May Shed Metal Flakes
AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.
Product
Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0451-2025·2024-11-20
Surgical forceps and clamps recalled due to potential metal flake contamination
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
Product
Halyard ENT - Medical convenience kits Model Number: VMED011-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0388-2025·2024-11-20
Halyard AORTA PACK Surgical Kit Recalled for Loose Metal Flakes
Halyard AORTA PACK surgical kits are recalled because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.
Product
Halyard AORTA PACK - Medical convenience kits Model Number: ESJH004-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0366-2025·2024-11-20
Stryker electrosurgical smoke evacuation pencils recalled for unintended activation risk
Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0463-2025·2024-11-20
Operating Table May Stop Unexpectedly During Surgery Due to Control Error
MEERA CL mobile operating tables may experience an error code that causes the table to stop moving unexpectedly during surgery, resulting in procedural delays.
Product
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
Category
Medical Device
Distribution
Distributed nationwide