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 the agency’s own highest classification or reported deaths or serious injuries, 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

12076–12100 of 27470

HighFDA (Devices)·Z-1110-2021·2021-02-24
Combat Medical Systems Recalls Valkyrie LTOWB Blood Collection Kits
Combat Medical Systems is recalling 531 Valkyrie LTOWB blood collection kits due to a potential for bent or disconnected needles.
Product
Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2021·2021-02-24
Combat Medical Systems Recalls Valkyrie LTOWB Blood Administration Kits
Combat Medical Systems is recalling 953 Valkyrie LTOWB Administration Sets due to a potential for bent or disconnected needles.
Product
Valkyrie LTOWB Administration (P/N 80-821 NSN 6515016862401). Blood convenience kit. The Valkyrie LTOWB Administration Set contains the items needed to administer the blood to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2021·2021-02-24
Baxter Gambro Cartridge Blood Transport System Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems for hemodialysis due to complaints of kinked access lines observed during treatment.
Product
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1118-2021·2021-02-24
Baxter Gambro Cartridge Blood Set Prime Line Recalled for Kinked Lines
Baxter Healthcare is recalling Gambro Cartridge Blood Set Prime Line units because kinked access lines were observed during hemodialysis treatments.
Product
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1116-2021·2021-02-24
Medtronic Recalls Cerebrospinal Fluid Valves Due to Radiopaque Marking Issues
Medtronic Neurosurgery is recalling 22,528 units of STRATA II cerebrospinal fluid valves and shunts worldwide because radiopaque markings may vary in visibility under imaging.
Product
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHUNT 27740 STRATA NSC SNAP REG 120CM, 27812 - VALVE 27812 STRATA II SM EXTRACTED, 27814 - SHUNT…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2021·2021-02-24
Confirm Biosciences Recalls Healgen COVID-19 Rapid Test Cassettes
Confirm Biosciences is recalling Healgen COVID-19 Rapid Test Cassettes because they were distributed to non-certified labs and not validated for fingerstick use.
Product
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2021·2021-02-24
Cairn Diagnostics Recalls 13C-Spirulina Gastric Emptying Breath Test Kits
Cairn Diagnostics is recalling 103 kits of the 13C-Spirulina Gastric Emptying Breath Test due to a potential for false negative diagnoses of gastroparesis.
Product
13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis.
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-1073-2021·2021-02-17
Argon Medical Devices Recalls Transjugular Liver Biopsy Systems
Argon Medical Devices is recalling 863 TLAB 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 - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,
Category
Medical Device
Distribution
46 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-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
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-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-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-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
HighFDA (Devices)·Z-1026-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection.
Product
INJECTOR FORCEMAX UP 2MM CH 23G 3MM, model no. NM-401L-0523 - 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
HighFDA (Devices)·Z-1029-2021·2021-02-17
Aomori Olympus ForceMax Injector Recall Due to Inadequate Package Seals
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 2MM CH 25G 6MM, model no. NM-401L-0625 - 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
HighFDA (Devices)·Z-1023-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - 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
HighFDA (Devices)·Z-1014-2021·2021-02-17
Aomori Olympus Endoscopic Injector Recall Due to Package Seal Defects
Aomori Olympus is recalling specific endoscopic injectors because inspection found some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 5MM, model no. NM-400L-0525 - 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
HighFDA (Devices)·Z-0977-2021·2021-02-17
Aomori Olympus Recalls KD-620LR Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-620LR Electrosurgical Snare units because inspection found some sterile packages have inadequate seals, posing an infection risk.
Product
KD-620LR ELECTROSURGICAL SNARE, model no. KD-620LR - Product Usage: Used with endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1013-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax injectors because some sterile packages have partial heat seals, creating a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - 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
HighFDA (Devices)·Z-1008-2021·2021-02-17
Aomori Olympus Recalls ForceMax Injectors Due to Package Seal Defects
Aomori Olympus is recalling ForceMax injectors because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and cause infection.
Product
INJECTOR FORCEMAX SIF 270CM 23G 4MM, model no. NM-400Y-0423 - 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

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12076–12100 of 27470