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.

1801–1825 of 21710

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-2337-2025·2025-08-27
Strep A test kits recalled after shipment to unlicensed purchasing customers
Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2330-2025·2025-08-27
Suture retention devices recalled with no reason stated in FDA record
DRS Vascular is recalling 264 Q-Stop Suture Retention Devices. The FDA enforcement record for this action carries a placeholder in place of a stated reason for the recall.
Product
Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2335-2025·2025-08-27
Calcium test slides recalled after calibration failures delayed patient results
VITROS Chemistry Products Ca Slides, catalog number 145 0261, generations 67 and above, are recalled because calibration failures on VITROS XT systems delay calcium test results. 174,215 units are affected.
Product
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2313-2025·2025-08-20
SIGNA Premier XT patient table caster lock checks may have been missed
GE SIGNA Premier 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. 2 units affected.
Product
GE SIGNA Premier XT (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 (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 (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-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 (Drugs)·D-0583-2025·2025-08-20
Theophylline extended-release tablets failed dissolution at long-term stability testing
Theophylline extended-release tablets 400 mg from Glenmark are being recalled because dissolution results at the long-term shelf life stability interval did not comply with L3 stage criteria. 22,656 bottles affected.
Product
THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
Category
Drug
Distribution
Distributed nationwide
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 (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#…
Category
Food
Distribution
2 states
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-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-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 (Devices)·Z-2309-2025·2025-08-20
SIGNA PET/MR imager recalled over unconfirmed patient table caster lock checks
GE HealthCare is recalling 97 SIGNA PET/MR imagers because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2288-2025·2025-08-20
Prosthesis heads carry inconsistent size terminology and color coding on labeling
Prosthesis Head B, 28 mm with 7 mm neck length, is being recalled because of inconsistent size terminology and colour coding used on the labeling. 46 units are affected.
Product
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2324-2025·2025-08-20
Anorectal manometry kit outer label shows the manufacturing date as expiry
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
Product
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
Category
Medical Device
Distribution
Distributed nationwide
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-2304-2025·2025-08-20
SIGNA Premier MRI system recalled over unconfirmed patient table caster lock maintenance
GE HealthCare is recalling 214 SIGNA Premier MRI systems because the planned maintenance step that checks the patient table caster locks may not have been performed.
Product
GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
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-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
ModerateFDA (Food)·H-0444-2025·2025-08-20
Lithium orotate 5 mg product recalled after failing to meet labeled potency
Lithium Orotate 5 mg distributed by Enjoy Nutrition, LLC is recalled nationwide for failing to meet its labeled potency, following a recall by the ingredient supplier.
Product
Lithium Orotate, 5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 702730893968, 702730894064
Category
Food
Distribution
Distributed nationwide
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-2311-2025·2025-08-20
SIGNA Voyager AIR MRI recalled over unverified patient table caster lock maintenance
GE HealthCare is recalling SIGNA Voyager AIR (China Only) MRI systems because a planned maintenance step checking the patient table caster locks may not have been performed.
Product
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states