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.

826–850 of 3531

ModerateFDA (Devices)·Z-2079-2024·2024-05-29
Medline 10ml Syringes Recalled for Exceeding FDA Clearance Range
Jiangsu Shenli Medical is recalling 39,200 Medline non-sterile syringes (Model 91850) because the device sizes and configurations exceed the range approved by the FDA's 510(k) clearance. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED LIDO Model/Catalog Number: 91850 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2061-2024·2024-05-29
Medline Non-Sterile Syringes Recalled Due to Manufacturing Specification Mismatch
Medline non-sterile 5mL syringes (model 91829) are recalled because they were manufactured outside the scope of FDA-approved specifications. About 35,000 units are affected.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW Model/Catalog Number: 91829 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2069-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled for Unapproved Sizes and Configuration
Medline non-sterile syringes are recalled because their piston sizes and configurations exceed those approved by the FDA. No injuries have been reported. Approximately 230,800 units were distributed nationwide across six states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE Model/Catalog Number: 91837 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2115-2024·2024-05-29
GMAX SYR 35ML Non-Sterile Syringes Recalled for Regulatory Non-Compliance
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
Product
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2075-2024·2024-05-29
Medline 20mL Non-Sterile Syringes Recalled for Configuration Non-Conformance
Medline syringes (Model 91845) distributed across six US states are recalled because their piston configurations don't match FDA-cleared design specifications. The recall affects approximately 40,800 units.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L BLUE SALINE Model/Catalog Number: 91845 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2045-2024·2024-05-29
MEDLINE SYR 60ML Non-Sterile Syringes Recalled for Clearance Violation
Jiangsu Shenli Medical is recalling 1,117,800 MEDLINE SYR 60ML non-sterile syringes (Model 83080) because certain syringe sizes and configurations exceed what was approved under the manufacturer's FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 60ML L/L Model/Catalog Number: 83080 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2066-2024·2024-05-29
Non-sterile Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production is recalling approximately 749,400 non-sterile syringes (10ml) distributed under the Medline brand because their sizes and configurations were not cleared by FDA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW Model/Catalog Number: 91834 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2095-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-range configuration variations
Medline's non-sterile syringes (Model 91877) are recalled because their sizes and configurations exceed what was approved under the firm's 510(k) clearance. The regulatory non-compliance affects 3,840 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L YELLOW LIDO Model/Catalog Number: 91877 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2024·2024-05-29
Medline Syringes Recalled: Device Configuration Outside FDA Clearance Scope
Medline is recalling 10ML non-sterile syringes (Model 91857) distributed nationwide because the device configurations fall outside the FDA-cleared range for this product.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN CONT Model/Catalog Number: 91857 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2089-2024·2024-05-29
FDA Recalls Medline Syringes Manufactured Outside Approved Specifications
Jiangsu Shenli Medical Production Co. is recalling 9,800 Medline non-sterile syringes (Model 91866, Lot 63722070002) because the devices were manufactured in sizes and configurations outside the firm's FDA-cleared scope.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED NITRO Model/Catalog Number: 91866 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2065-2024·2024-05-29
Medline non-sterile syringes recalled for unauthorized syringe sizes and configurations
Medline non-sterile syringes (Model 91833) are being recalled because the manufactured syringe sizes and configurations do not match the company's regulatory clearance. Consumers should stop using the recalled lot numbers.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L WHITE Model/Catalog Number: 91833 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2074-2024·2024-05-29
Medline non-sterile syringes recalled for exceeding 510(k) clearance scope
Jiangsu Shenli Medical recalled 18,900 Medline non-sterile syringes (Model 91842) because their sizes and configurations exceed the FDA's approved scope under the firm's 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L PURPLE Model/Catalog Number: 91842 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2128-2024·2024-05-29
MEDLINE 20ML Non-Sterile Syringes Recalled for Configurations Outside FDA Clearance
MEDLINE non-sterile syringes (Model 91843) are being recalled because the product's sizes and configurations fall outside the scope of devices approved under the manufacturer's FDA 510(k) submission. The syringes were distributed nationwide across multiple U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L PURPLE Model/Catalog Number: 91843 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2051-2024·2024-05-29
Non-sterile syringes recalled for manufacturing outside FDA-cleared specifications
Jiangsu Shenli Medical is recalling 619,200 MEDLINE non-sterile syringes (Model 83087) manufactured in configurations outside FDA-approved specifications. The recall affects units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/S Model/Catalog Number: 83087 Product Description: NON-Sterile syringes without needles for single usef Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2122-2024·2024-05-29
GMAX Blue Syringes Recalled for Out-of-Range Design Configurations
Jiangsu Shenli Medical recalled 9,800 GMAX blue syringes because their sizes and configurations fall outside FDA's clearance range. Affected units were distributed nationwide to healthcare facilities and retailers.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL Blue syringe Model/Catalog Number: TS2210B-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2024·2024-05-22
Magnesium Citrate Laxative Recalled for Bacterial Contamination
CVS Health Magnesium Citrate Saline Laxative Oral Solution is being recalled nationwide due to microbial contamination with Acetobacter nitrogenifigens bacteria in lot A81506.
Product
MAGNESIUM CITRATE — MAGNESIUM CITRATE (CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2024·2024-05-22
Gordofilm Wart Remover Recalled Due to Manufacturing Deviations
Gordofilm Wart Remover by Gordon Laboratories is being recalled nationwide due to Current Good Manufacturing Practice (cGMP) deviations. The FDA classified this as a Class II recall on May 13, 2024.
Product
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0501-2024·2024-05-22
OTC Magnesium Citrate laxative recalled for microbial contamination
Meijer Magnesium Citrate Saline Laxative is being recalled due to microbial contamination. Lot A81834 (expiration 1/31/2026) was distributed nationwide; consumers should stop using the product.
Product
MAGNESIUM CITRATE — MAGNESIUM CITRATE (MAGNESIUM CITRATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1222-2024·2024-05-15
Dietary Supplement Labeling Error: Kirkman 5-MTHF Folic Acid Misdeclared
Kirkman 5-MTHF dietary supplement has a labeling error: the Supplement Facts incorrectly states 5000mcg Folic Acid per serving instead of 1000mcg. Lot# 477-0016, exp. 08/2025.
Product
Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 9703,
Category
Drug
Distribution
6 states
ModerateFDA (Devices)·Z-1786-2024·2024-05-15
Evidence MultiSTAT analyzer foam gasket malfunction may affect test accuracy
Randox Laboratories is recalling 40 units of the Evidence MultiSTAT analyzer because a foam gasket defect may allow light to leak into the camera during testing, potentially affecting result accuracy and delaying reporting.
Product
Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0490-2024·2024-05-15
Prescription skin cleanser recalled nationwide due to subpotency
Acella Pharmaceuticals recalled 7,104 bottles of Sodium Sulfacetamide 10% Sulfur 5% Cleanser nationwide because the product contained less active ingredient than labeled. The recall was terminated in December 2025.
Product
SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER — SODIUM SULFACETAMIDE 10 SULFUR 5 CLEANSER (SULFACETAMIDE SODIUM AND SULFUR)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0492-2024·2024-05-15
Clorazepate Dipotassium Tablets Recalled for Tablet Discoloration Defects Nationwide
Aurobindo Pharma USA Inc. is recalling 6909 bottles of Clorazepate Dipotassium 7.5 mg tablets due to visible discoloration with yellow and dotted spots. No illnesses or injuries have been reported.
Product
CLORAZEPATE DIPOTASSIUM — CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1785-2024·2024-05-15
Stryker Dynamic Mesh Mislabeled with Incorrect Catalog Number
Stryker shipped 63 units of cranial mesh labeled as catalog 56-90614 (Gold) but actually containing 56-90314 (Blue) mesh. The mislabeling may cause procedural delays.
Product
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Category
Medical Device
Distribution
Distributed nationwide
ModerateNHTSA·22V883000·2024-05-11
Winnebago Travel Trailers Recalled for Sharp Cabinet Door Handles
Winnebago is recalling certain 2021-2022 travel trailers because cabinet door and drawer handles may have sharp edges. Dealers will replace the handles free of charge.
Product
WINNEBAGO — 2022 WINNEBAGO HIKE
Category
Vehicle
Distribution
Distributed nationwide
ModerateCPSC·24231·2024-05-09
Spin Swivel Chairs Recalled Due to Fall Hazard
Spin Swivel Chairs sold online at article.com from July 2021 through June 2023 are being recalled because the swivel chair's base can break, posing a fall hazard. No injuries have been reported.
Product
Spin Swivel Chairs
Category
Consumer Product
Distribution
Distributed nationwide