State

Indiana product recalls

73,104 recalls have nationwide distribution and so reach Indiana. 9,585 additional recalls listed Indiana specifically in their distribution scope.

What the numbers show

Total: 9,585
Critical: 1,913
Severe: 2,148
Most recent: 2026-09-23

Of the 9,585 recalls naming Indiana we have scored against our rubric, 1,913 (20%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,148 (22%) are Severe.

Which agencies issued them

These figures cover only the 9,585 recalls whose distribution notice names Indiana specifically. The 73,104 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

12126–12150 of 82689

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-2106-2024·2024-05-29
Wolf Medical Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 35 mL syringes because their piston sizes and configurations exceed the range cleared by the FDA 510(k) authorization.
Product
Brand Name: Wolf Medical Product Name: 35 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR35L 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-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-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-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-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-2056-2024·2024-05-29
MEDLINE Non-Sterile Syringes Model 91822 Recalled for Unapproved Configuration
MEDLINE non-sterile syringes (Model 91822) are recalled because their sizes and configurations fall outside the FDA-approved range under the manufacturer's 510(k) clearance. Approximately 12,000 units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L BLUE Model/Catalog Number: 91822 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2024·2024-05-29
MEDLINE Piston Syringes Recalled for Out-of-Range Specifications
Jiangsu Shenli Medical Production recalled 1.7 million MEDLINE piston syringes because the devices' sizes and configurations exceed what was cleared by the FDA. The affected syringes were distributed nationwide across multiple states.
Product
Brand Name: MEDLINE Product Name: SYR 1ML TB Model/Catalog Number: 83089 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2076-2024·2024-05-29
Medline 10ML Syringes Recalled Due to Regulatory Specification Non-Compliance
Medline is recalling 10ML syringes in multiple lot codes because the device sizes fall outside the range cleared by the FDA for this product. The affected products were distributed to consumers in six states.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2071-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Unapproved Device Configurations
Jiangsu Shenli Medical is recalling 178,400 non-sterile syringes sold under the Medline brand because the device configurations exceed what was cleared under the firm's FDA 510(k) application.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L YELLOW Model/Catalog Number: 91839 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2116-2024·2024-05-29
GMAX 60ML Non-Sterile Syringes Recalled for Design Non-Compliance
Jiangsu Shenli Medical is recalling 1.59 million GMAX 60ML non-sterile syringes because the syringe sizes and configurations exceed what the FDA cleared the manufacturer to produce. The syringes were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 60ML/LL syringe Model/Catalog Number: TS2260L-M 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-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-2111-2024·2024-05-29
FDA Recalls GMAX Non-Sterile 10ML Syringes Due to Non-Compliant Manufacturing Specifications
GMAX non-sterile syringes are being recalled because their actual sizes and configurations exceed the range of specifications the manufacturer obtained FDA clearance for.
Product
Brand Name: GMAX Product Name: SYR 10ML/LL syringe Model/Catalog Number: TS2210L-M 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-2049-2024·2024-05-29
Medline non-sterile syringes recalled for manufacturing outside FDA clearance scope
Medline non-sterile syringes (Model 83084) are being recalled because they were manufactured in sizes and configurations outside the scope of FDA clearance.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L Model/Catalog Number: 83084 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2073-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Range Sizes and Configurations
Medline non-sterile syringes (Model 91841) are recalled because certain size and configuration variants were not included in the FDA-cleared 510(k) specifications. These uncleared configurations should not have been distributed.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE Model/Catalog Number: 91841 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2121-2024·2024-05-29
GMAX SYR 10ML Control Syringes Recalled for Exceeding Device Specifications
Jiangsu Shenli Medical Production is recalling GMAX SYR 10ML Control syringes because the device specifications exceed FDA-cleared limits. Approximately 348,800 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 10ML Control syringe Model/Catalog Number: TS3210L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2080-2024·2024-05-29
Medline Heparin Syringes Recalled for Exceeding FDA Approved Scope
Medline non-sterile syringes (Model 91851) are being recalled because their piston sizes and configurations exceed what the FDA approved. Approximately 7,000 units distributed in six states are affected.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED HEPARIN Model/Catalog Number: 91851 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2083-2024·2024-05-29
Medline Syringes Recalled for Operating Outside FDA-Cleared Configurations
Jiangsu Shenli Medical is recalling 12,600 non-sterile syringes (Model 91855) distributed nationwide. The syringes operate in sizes and configurations not covered by the firm's FDA clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 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-2063-2024·2024-05-29
FDA Recalls Medline Non-Sterile Syringes for Regulatory Non-Compliance
Medline has recalled approximately 325,500 non-sterile syringes (Model 91831) due to syringe sizes and configurations that fall outside FDA-cleared specifications. The syringes were distributed nationwide and manufactured by Jiangsu Shenli Medical Production Co., Ltd.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L GREEN Model/Catalog Number: 91831 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2096-2024·2024-05-29
Medline Piston Syringes Recalled for Non-Compliant Manufacturing Specifications
Jiangsu Shenli Medical is recalling 12,160 Medline piston non-sterile syringes (Model 91878) because manufacturing sizes and configurations exceed FDA 510(k) clearance scope. Distribution was nationwide via U.S. ports.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2057-2024·2024-05-29
Non-sterile syringes recalled for configurations exceeding FDA clearance
Medline is recalling approximately 95,200 non-sterile 5mL syringes (Model 91825) distributed nationwide because syringe sizes and configurations exceed the scope of FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L RED Model/Catalog Number: 91825 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide