Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

1551–1575 of 13446

SevereFDA (Devices)·Z-0579-2026·2025-12-03
Olympus Duodenovideoscope Reprocessing Procedures Updated to Address Reported Infections
Olympus is updating reprocessing materials and instructions for the TJF-Q190V duodenovideoscope (7,023 units nationwide) following continued reports of infections. Users must follow updated reprocessing instructions closely.
Product
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessorie
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0531-2026·2025-12-03
SJM Pericardial Patch Recalled for Tensile Strength Deficiency
Glycar SA recalls SJM Pericardial Patches (Model C0914) that may not meet required tensile strength specifications. 30 units were distributed in the US.
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0532-2026·2025-12-03
SJM Pericardial Patch Recalled for Inadequate Tensile Strength Specification
Glycar SA is recalling 18 units of SJM Pericardial Patch (Model C0510, lot T2506245) because the devices may not meet required tensile strength specifications. Affected patients and healthcare providers should consult regarding device performance.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0570-2026·2025-12-03
Olympus Ligating Device Recalled Due to Loop Release Failure
Olympus is recalling the HX-400U-30 ligating device used in endoscopy procedures because the nylon loop may fail to release properly from patient anatomy. The recall affects 7,803 units distributed throughout the United States.
Product
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0668-2026·2025-12-03
IV Administration Sets: Risk of Medication Backflow and Priming Failure
B Braun Medical Inc recalls IV Administration Sets due to potential medication backflow from secondary into primary containers and priming failure. Worldwide distribution to US, Canada, Germany, Guatemala, and Singapore.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML,
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0681-2026·2025-12-03
IV Administration Sets recalled for potential medication backflow
B Braun Medical Inc is recalling 63,192 IV Administration Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime the sets.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 13
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0658-2026·2025-12-03
IV Administration Set Recalled Due to Potential Medication Backflow and Occlusion
B Braun Medical Inc recalls IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV SET 15DR 3 CARESITE, 124
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0696-2026·2025-12-03
B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical is recalling 4,536 IV Administration Sets worldwide due to potential backflow of medication from secondary containers into primary containers and inability to prime. This could compromise safe medication delivery.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/ 15 DROPS/ML
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0687-2026·2025-12-03
B Braun IV Administration Sets Recalled for Backflow and Occlusion Risk
B Braun Medical is recalling IV administration sets due to potential backflow of medication from secondary containers into primary containers and inability to prime. The defect may result in wrong medication delivery or medication delivery failure.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/CARESITE EXT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0713-2026·2025-12-03
IV Administration Sets Risk Medication Backflow and Occlusion
B Braun Medical recalls SAFELINE IV administration sets due to potential medication backflow from secondary containers and inability to prime, affecting 46,250 units distributed worldwide.
Product
SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Numb
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0721-2026·2025-12-03
Mindray Isoflurane V90 Vaporizer Recalled for Potential Anesthesia Leakage
Mindray's Isoflurane V90 Electronic Vaporizer with A9 Anesthesia System is being recalled due to potential anesthesia leakage. The recall affects 54 units distributed across multiple US states and Canada.
Product
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0606-2026·2025-12-03
FDA Recalls Anesthesia IV Sets Over Medication Backflow and Occlusion Risk
B Braun Medical is recalling 32,436 Anesthesia IV Sets used with multiple infusion pumps due to potential backflow of medication from secondary containers and inability to prime. No illnesses or injuries have been reported.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 108
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0626-2026·2025-12-03
IV Administration Set Component Recalled for Potential Medication Backflow
B Braun Medical Inc is recalling IV administration set components that may allow medication to flow backward from secondary containers or prevent proper priming. The recall affects approximately 381,850 units distributed worldwide.
Product
Caresite utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Primary Gravity Filtered Set with 2 CARE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0716-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion
B Braun Medical Inc is recalling Outlook IV administration sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No illnesses reported.
Product
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DR W/2 CARESITE FILT
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0680-2026·2025-12-03
IV Administration Sets Recalled Due to Backflow and Occlusion Risks
B Braun Medical Inc is recalling approximately 12,200 IV Administration Sets worldwide due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. No illnesses have been reported.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, IN
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0692-2026·2025-12-03
IV Administration Sets recalled due to backflow and occlusion potential
B. Braun Medical Inc is recalling 45,288 units of IV Administration Sets due to potential backflow of medication from secondary containers into primary containers and inability to prime, which could cause improper medication delivery or line contamination.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 130 IN. IV ADMIN SET W/ 9 I
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0634-2026·2025-12-03
Extension Sets for IV Pumps Recalled Due to Medication Backflow Risk
B Braun Medical is recalling extension sets used with infusion pumps due to potential backflow of medication between IV containers and inability to prime. No injuries have been reported.
Product
Extension Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48 IN.;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0612-2026·2025-12-03
B Braun IV Administration Set Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling 88,200 units of Anesthesia IV Sets due to potential backflow of medication from secondary IV containers into primary containers and inability to prime. The sets are distributed worldwide.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D 2 CARESITE LA
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0650-2026·2025-12-03
IV Administration Sets Pose Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 6,650 IV Administration Sets due to potential backflow of medication into primary containers and inability to prime. The issue could compromise medication delivery in patients.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD SET CARESITE 127 IN.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0677-2026·2025-12-03
IV Administration Set Recalled for Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 5,952 IV Administration Sets due to a potential malfunction that could allow medication to flow backward into primary containers and prevent proper priming.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. 15DR 2SAFELINE 1CARESITE 1S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0674-2026·2025-12-03
IV Administration Set Recalled for Potential Medication Backflow and Priming Issues
B Braun Medical Inc is recalling IV Administration Sets due to potential backflow of medication from secondary to primary IV containers and inability to prime. No illnesses have been reported.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMINISTRATION SET WITH
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0613-2026·2025-12-03
B Braun Anesthesia IV Sets Recalled Due to Backflow and Occlusion
B Braun Medical Inc is recalling 19,320 Anesthesia IV Sets due to potential backflow of medication and inability to prime. The defect affects sets used with specific B Braun infusion pumps in anesthesia.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 2-HIGH FLOW STPCK
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0608-2026·2025-12-03
B Braun IV Administration Sets Recalled for Medication Backflow Risk
B Braun Medical Inc is recalling 14,712 Anesthesia IV Sets due to potential backflow of medication and priming failure that could affect medication delivery.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0654-2026·2025-12-03
IV Administration Sets Recalled for Potential Medication Backflow and Occlusion Risk
B Braun Medical Inc is recalling 1,861,111 IV administration sets used with infusion pumps due to potential medication backflow into primary IV containers and inability to prime.
Product
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ANES 15DROP W/2 CARESITE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0610-2026·2025-12-03
Anesthesia IV Sets Recalled Due to Medication Backflow and Occlusion Risk
B Braun Medical is recalling 10,536 Anesthesia IV Sets that may allow medication to flow backward from secondary IV bags into primary bags or fail to prime properly during use.
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 15D, 144 IN.; Cat
Category
Medical Device
Distribution
0 states

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1551–1575 of 13446