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

2051–2075 of 5038

SevereFDA (Devices)·Z-1282-2021·2021-03-31
Hitachi Arietta 850 Ultrasound System Recalled for Acoustic Output Error
Hitachi Medical Systems America Inc. is recalling Arietta 850 ultrasound systems with specific software versions due to an error that can cause acoustic output to exceed regulatory limits.
Product
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1284-2021·2021-03-31
Caire Diagnostics Recalls FenomPro Devices Due to Erroneous High FeNO Readings
Caire Diagnostics is recalling FenomPro devices because calibration drift and software errors may cause erroneously high FeNO readings, potentially leading to premature discontinuation of asthma treatment.
Product
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. Fenom Pro should not be used in critical care, emergency care or in anesthesiology.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1307-2021·2021-03-31
Biomerieux Recalls VITEK 2 Systems Due to HL7 Software Defect
Biomerieux is recalling 8,786 VITEK 2 systems worldwide due to a software defect that may cause false susceptible results when using HL7 communication.
Product
VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short incubation). VITEK 2 is an automated system consisting of instruments, software and reagent cards desi
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1280-2021·2021-03-31
Baxter Recalls Prismaflex Preventative Maintenance Kits Due to Tubing Performance Variability
Baxter Healthcare is recalling Prismaflex Preventative Maintenance Kits and spare part kits because tubing performance variability may cause alarms during or after system self-tests.
Product
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1195-2021·2021-03-24
Medtronic Custom Perfusion Pack Recalled for Bacterial Endotoxin Levels
Medtronic is recalling 4 units of Custom Perfusion Packs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filte
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1263-2021·2021-03-24
Heartspan Transseptal Needle Recall Due to Tip Curvature Mismatch
Merit Medical Systems is recalling Heartspan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Product
Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1196-2021·2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1264-2021·2021-03-24
Imactis NaviKit Stereotaxic Accessory Recalled for Mechanical Defect
Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.
Product
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1262-2021·2021-03-24
Merit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch
Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.
Product
HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1197-2021·2021-03-24
Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin
Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.
Product
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is coll
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1192-2021·2021-03-24
Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk
Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.
Product
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1247-2021·2021-03-17
Medtronic Guide Catheter Recalled for Potential Sterility Compromise
Medtronic Vascular is recalling 10 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Product
Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1211-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1238-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1224-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1244-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1212-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 26mm Material Number: 66-226 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1232-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery, requiring revision.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1246-2021·2021-03-17
Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise
Medtronic Vascular is recalling 9 units of 6F Launcher Guide Catheters because unsealed pouches may compromise sterility.
Product
Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1207-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 16mm Material Number: 66-116 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1201-2021·2021-03-17
Medtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects
Medtronic is recalling 33,430 Valiant Navion Thoracic Stent Graft Systems worldwide due to endoleaks, stent fractures, and ring enlargement.
Product
Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1217-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 38mm Material Number: 66-238 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1222-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 48mm Material Number: 66-348 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1221-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Defect
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1239-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide

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2051–2075 of 5038