Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

1576–1600 of 21588

ModerateFDA (Devices)·Z-2345-2025·2025-08-27
ELISA sample tip racks recalled over internal label misidentifying tip type
Dynex Agility Sample Tips, model 67910 lot 863366, are recalled because the internal rack label reads reagent tip rack, causing the instrument to misidentify the tips and preventing their use. 237 units are affected.
Product
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2316-2025·2025-08-20
SIGNA Hero XT patient table caster lock checks may have been missed
GE SIGNA Hero XT MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Product
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2312-2025·2025-08-20
SIGNA Architect AIR MRI recalled over unverified patient table caster lock maintenance
GE HealthCare is recalling 151 SIGNA Architect AIR (China Only) MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2302-2025·2025-08-20
Optima MR450w 1.5T MRI recalled where caster lock maintenance may be unperformed
GE HealthCare is recalling 1,372 Optima MR450w 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2306-2025·2025-08-20
Discovery MR750 3.0T systems recalled over patient table caster lock maintenance gap
GE HealthCare is recalling 330 Discovery MR750 3.0T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2292-2025·2025-08-20
Bartels Legionella urinary antigen kits may contain particulate matter
Bartels ELISA Legionella Urinary Antigen kits are being recalled because two lots have the potential to contain particulate matter. 968 kits are affected.
Product
Bartels ELISA Legionella Urinary Antigen. Model Number: B1029-440. In Vitro Diagnostic test kit for the presumptive diagnosis of past or current Legionnaires Disease.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0443-2025·2025-08-20
Lithium orotate 2.5 mg product recalled for failing labeled potency specification
Lithium Orotate 2.5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency. The action follows a recall by the ingredient supplier.
Product
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2301-2025·2025-08-20
Discovery MR450 1.5T scanners recalled over patient table caster lock maintenance
GE HealthCare is recalling 19 Discovery MR450 1.5T MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2317-2025·2025-08-20
SIGNA Hero Elite patient table caster lock checks may have been missed
GE SIGNA Hero Elite MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Product
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2318-2025·2025-08-20
SIGNA Hero MAX patient table caster lock checks may have been missed
GE SIGNA Hero MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Product
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2289-2025·2025-08-20
Plastic trial heads carry inconsistent size terminology and color coding
Plastic Trial Head Brown with 7 mm neck length is being recalled because of inconsistent size terminology and colour coding used on the labeling. 17 units are affected.
Product
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0447-2025·2025-08-20
Mecene lithium orotate capsules recalled after an out of specification ingredient
Lithium Orotate capsules distributed by Mecene LLC are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.
Product
Lithium Orotate 2.5; 60 vegetarian capsules, Dietary Supplement; Distributed by Mecene LLC. 447 Sutter St., Suite 405, San Fransisco, CA 94108 2.5 mg UPC#: X002T4OPLL 10 mg UPC#: X0031AXVE9
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0445-2025·2025-08-20
Lithium orotate 10 mg product recalled for failing labeled potency standard
Lithium Orotate 10 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 10MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730894033, 702730894057
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2300-2025·2025-08-20
Signa Voyager MRI recalled where patient table caster lock checks unconfirmed
GE HealthCare is recalling 280 Signa Voyager MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2305-2025·2025-08-20
SIGNA UHP patient table caster lock checks may have been missed
GE SIGNA UHP MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. 3 units affected.
Product
GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2315-2025·2025-08-20
SIGNA Premier MAX patient table caster lock checks may have been missed
GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
Product
GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2298-2025·2025-08-20
Ultra IABP catheter kits carry indications not reviewed by the FDA
Insightra Ultra IABP Catheter Kits are being recalled because the device carries indications and compatibility claims not reviewed by the FDA, and its instructions are inconsistent with product training.
Product
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product Description: The Insightra Ultra IABP Catheter Kit is a 7 French catheter available wi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0584-2025·2025-08-20
Belsomra 10 mg tablets failed dissolution, which may delay sleep onset
Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.
Product
BELSOMRA — BELSOMRA (SUVOREXANT)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2319-2025·2025-08-20
SIGNA PET/MR AIR system recalled where caster lock maintenance may be missing
GE HealthCare is recalling SIGNA PET/MR AIR (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2321-2025·2025-08-20
Medication dispensing cabinets recalled after reports of delayed access during override workflow
BD is recalling 6,076 Pyxis MedBank and MedBank Mini automated dispensing cabinets after reports of delayed access to medication caused by the override and Add Item workflow.
Product
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH/169-112, BD PYXIS MEDBANK MINI 3HH-1HM/169-111, BD PYXIS MEDBANK MINI 3HH-1FG/169-110, BD PYXIS MEDBANK MINI 2HM-1FM/169-109, BD PYXIS MEDBANK MINI 2HH-
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0448-2025·2025-08-20
Weyland lithium orotate capsules recalled after an out of specification ingredient
Weyland Brain Nutrition Lithium Orotate capsules are being recalled as a downstream recall of a dietary supplement ingredient that was manufactured out of specification. About 185,482 capsules affected.
Product
Lithium Orotate, Weyland Brain Nutrition ; 60 vegetarian capsules, Dietary Supplement; Distributed by Enjoy Nutirtion, LLC. San Francisco, CA 94108, (415) 894-0537 2.5 mg UPC#: X001SBI13J 5 mg UPC#: X000PY16Z5 10 mg UPC#: X000T9B9B7 20 mg UPC#: X001VBLW8H 1000 MCG UPC#: X003SBV
Category
Food
Distribution
2 states
ModerateFDA (Food)·H-0446-2025·2025-08-20
Lithium orotate 20 mg product recalled after failing labeled potency testing
Lithium Orotate 20 mg distributed by Enjoy Nutrition, LLC is recalled nationwide because it does not meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 20MG, Distributed by Enjoy Nutrition, LLC. UPC#: none
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2310-2025·2025-08-20
SIGNA Artist Evo MRI recalled over unverified patient table caster lock checks
GE HealthCare is recalling 138 SIGNA Artist Evo MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·H-0454-2025·2025-08-20
Imported soda biscuits recalled for undeclared whole milk powder and wheat
Soda Biscuit (Sea Salt Fresh Milk Flavor), 360 g packages imported by Shang Hao Jia, Inc., is recalled because the label does not declare whole milk powder and wheat. 4,800 units are affected.
Product
Soda Biscuit (Sea Salt Fresh Milk Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865031
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-2320-2025·2025-08-20
SIGNA PET/MR AIR Plus recalled over unperformed patient table caster lock maintenance
GE HealthCare is recalling SIGNA PET/MR AIR Plus (China Only) systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states