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

15176–15200 of 39988

HighFDA (Devices)·Z-1060-2021·2021-02-17
Aomori Olympus Vizishot Aspiration Needle Recall for Package Seal Defects
Aomori Olympus is recalling Vizishot 22G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if used.
Product
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0958-2021·2021-02-17
ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices are distributed worldwide and across multiple U.S. states.
Product
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2021·2021-02-17
Becton Dickinson Recalls BioGX SARS-CoV-2 Reagents Due to Mislabeled Pouches
Becton Dickinson is recalling 938 kits of BioGX SARS-CoV-2 Reagents because some master mix pouches may be mislabeled, potentially leading to false negative test results.
Product
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for Inadequate Package Seals
Aomori Olympus is recalling ForceMax Lower 23G 5MM injectors because some sterile packages have inadequate seals, posing an infection risk.
Product
INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-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-1065-2021·2021-02-17
Aomori Olympus Biliary Stent Recalled for Inadequate Package Seals
Aomori Olympus is recalling biliary stents because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
PBD-203-0707 BILIARY STENT, model no. PBD-203-0707 -Product Usage: Used with endoscopes for endoscopic retrograde biliary drainage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2021·2021-02-17
Roche 9180 Electrolyte Analyzer Recalled for Incorrect Calcium Display Arrows
Roche Diagnostics is recalling 1,214 units of the 9180 Electrolyte Analyzer because the device may display incorrect arrow directions for ionized calcium results when configured in mg/dL, potentially leading to misinterpretation.
Product
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1021-2021·2021-02-17
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 if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 5MM, model no. NM-400U-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-1054-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling NA-401D-1321 aspiration needles because inspection found inadequate package seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-401D-1321 ASPIRATION NEEDLE, model no. NA-401D-1321 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Needles Due to Seal Defects
Aomori Olympus is recalling 260,395 NeedleMaster needles in the US because some sterile packages have inadequate seals, posing an infection risk.
Product
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2021·2021-02-17
Aomori Olympus Recalls KD-650L Electrosurgical Snare Due to Seal Defects
Aomori Olympus Co., Ltd. is recalling KD-650L Electrosurgical Snare units because some sterile packages have inadequate seals, posing an infection risk.
Product
KD-650L ELECTROSURGICAL SNARE, model no. KD-650L - 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-0964-2021·2021-02-17
Aomori Olympus Recalls B7-2LA Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2LA Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2021·2021-02-17
Aomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
Aomori Olympus is recalling Vizishot 21G aspiration needles because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2021·2021-02-17
ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices were distributed in the U.S. and Belgium.
Product
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1003-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, which could lead to infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 2.5MM, model no. NM-400U-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-1028-2021·2021-02-17
Aomori Olympus ForceMax Injector Recalled for 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 23G 6MM, model no. NM-401L-0623 - 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-1034-2021·2021-02-17
Aomori Olympus Recalls NeedleMaster Endoscopic Injection Needles Due to Seal Defects
Aomori Olympus is recalling NeedleMaster endoscopic injection needles because some sterile packages have inadequate seals, posing a risk of infection.
Product
NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1002-2021·2021-02-17
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 if used.
Product
INJECTOR FORCEMAX LOWER 23G 4MM, model no. NM-400U-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-0986-2021·2021-02-17
Aomori Olympus Electrosurgical Snare Recalled for Inadequate Package Seals
Aomori Olympus is recalling SD-210U-25 electrosurgical snares because some sterile packages have inadequate seals, posing a risk of infection.
Product
SD-210U-25 ELECTROSURGICAL SNARE, SD-210U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1022-2021·2021-02-17
Aomori Olympus Recalls Endoscopic Injectors Due to Package Seal Defects
Aomori Olympus is recalling endoscopic injectors because some sterile packages have inadequate seals, posing a risk of infection if non-sterile equipment is used.
Product
INJECTOR FORCEMAX LOWER 25G 6MM, model no. NM-400U-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-1108-2021·2021-02-17
Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Clot Time Issues
Helena Laboratories is recalling Cascade Abrazo aPTT Test Cards due to intermittent potential for shorter than expected clot times.
Product
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1016-2021·2021-02-17
Aomori Olympus Recalls ForceMax Endoscopic Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax endoscopic injectors because some sterile packages have inadequate seals, which could lead to patient infection.
Product
INJECTOR FORCEMAX LOWER 23G 3MM, model no. NM-400U-0323 - 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-1020-2021·2021-02-17
Aomori Olympus Recalls ForceMax Lower Injectors Due to Seal Defects
Aomori Olympus is recalling ForceMax Lower injectors because some sterile packages have inadequate seals, posing an infection risk if used.
Product
INJECTOR FORCEMAX LOWER 23G 6MM 5/BX, model no. NM-400U-0623 - 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-0963-2021·2021-02-17
Aomori Olympus Recalls B7-2C Balloon Catheters Due to Seal Defects
Aomori Olympus is recalling B7-2C Balloon Catheters because some sterile packages have inadequate seals, which could allow non-sterile equipment to be used and lead to patient infection.
Product
B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0959-2021·2021-02-17
Prytime Medical REBOA Catheter Introducer Kit Recalled for Incorrect Needle Size
Prytime Medical Devices is recalling REBOA Catheter Introducer Kits because they may contain a 21G needle instead of the correct 18G needle, which could cause procedure delays or injury.
Product
PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5…
Category
Medical Device
Distribution
Distributed nationwide

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15176–15200 of 39988