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

2101–2125 of 5111

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
SevereFDA (Devices)·Z-1209-2021·2021-03-17
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, 20mm Material Number: 66-120 - 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-1236-2021·2021-03-17
Pioneer Surgical Technology Recalls CervAlign Anterior Cervical Plate System
RTI Surgical, Inc. 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, 100mm Material Number: 66-5100 - 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 o
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1220-2021·2021-03-17
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, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 42mm Material Number: 66-342 - 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-1226-2021·2021-03-17
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, 3Level, 60mm Material Number: 66-360 - 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-1204-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling 65 units of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - 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-1229-2021·2021-03-17
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, 4Level, 64mm Material Number: 66-464 - 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-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-1159-2021·2021-03-10
ReNovo Recalls Reprocessed Medical Devices Shipped as Sterile
ReNovo, Inc. is recalling 81 units of reprocessed medical devices that were shipped to customers labeled as sterile but were non-sterile.
Product
Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Con
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1156-2021·2021-03-10
Hamilton Heater Shaker Recalled Due to Fire Risk from Flammable Liquids
Hamilton Co is recalling 4,729 Heater Shaker units because flammable liquids entering the device can cause a fire.
Product
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1138-2021·2021-03-03
DeRoyal Recalls Non-Sterile Sternum Saw Blades in Surgical Packs
DeRoyal Industries is recalling 309 CV Basin Set Packs because the included sternum saw blades are not sterile.
Product
CV Basin Set Pack, REF numbers: a) 89-7935.11 b) 89-7935.12 c) 89-7935.13 d) 89-7935.14 e) 89-7935.15 f) 89-7935.16 Custom surgical procedure packs including sternum saw blades.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1149-2021·2021-03-03
Steris Recalls OT1000 Series Orthopedic Surgical Tables Due to Bond Separation
Steris is recalling 272 OT1000 Series Orthopedic Surgical Tables because a glued bond may separate, potentially causing unexpected movement during procedures.
Product
OT1000 Series Orthopedic Surgical Tables
Category
Medical Device
Distribution
40 states
SevereFDA (Drugs)·D-0267-2021·2021-03-03
CareFusion Recalls ChloraPrep Antiseptic Applicators for Potential Fungal Contamination
CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches in hot, humid climates.
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1114-2021·2021-02-24
Combat Medical Systems Recalls Fresh Whole Blood Donor Sets
Combat Medical Systems is recalling 954 Fresh Whole Blood Donor Sets due to a potential bent or disconnected needle in the kit components.
Product
Fresh Whole Blood Donor Set (P/N 80-801-D NSN 6515016640306) . Blood convenience kit. The Fresh Whole Blood Doner Set contains everything needed to test for ABO/Rh compatibility and collect the whole blood from donor.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1112-2021·2021-02-24
Combat Medical Systems Recalls Low Titer Type O FWB Transfusion Sets
Combat Medical Systems, LLC is recalling 1021 units of Low Titer Type O FWB Transfusion Sets due to the potential for bent or disconnected needles in the components.
Product
Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1075-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 247 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-0960-2021·2021-02-17
Cook Medical Kwart Retro-Inject Ureteral Stent Set Recalled for Material Defect
Cook Inc. is recalling 42 units of Kwart Retro-Inject Ureteral Stent Sets because they were manufactured with incorrect material, which may cause the stent to be stiffer and susceptible to degradation, breakage, or fragmentation.
Product
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-1076-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems Due to Sheath Separation
Argon Medical Devices is recalling 1,759 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-0950-2021·2021-02-17
Boston Scientific Recalls EMBLEM S-ICD Model A209 Due to Electrical Overstress
Boston Scientific is recalling 1,953 EMBLEM S-ICD Model A209 devices because electrical overstress may cause malfunction. The devices were distributed in the US and worldwide.
Product
EMBLEM S-ICD Model A209
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1010-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seal
Aomori Olympus is recalling ForceMax Up injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM, model no. NM-400L-0621 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1074-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy System Due to Sheath Separation
Argon Medical Devices is recalling the TLAB Transjugular Liver Biopsy System because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-1072-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 483 Transjugular Liver Biopsy Systems because a manufacturing error may cause the sheath to separate during use, potentially requiring surgical intervention.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,
Category
Medical Device
Distribution
46 states
SevereFDA (Devices)·Z-0951-2021·2021-02-17
Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Electrical Overstress
Boston Scientific is recalling 872 Emblem MRI S-ICD Model A219 devices because electrical overstress may lead to device malfunction.
Product
EMBLEM MRI S-ICD Model A219
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0990-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-240U-25 electrosurgical snares because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1077-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 583 Transjugular Liver Biopsy Systems due to a manufacturing error that may cause the sheath to separate during use.
Product
Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,
Category
Medical Device
Distribution
46 states

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2101–2125 of 5111