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

19201–19225 of 40124

HighFDA (Devices)·Z-0126-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 170,735 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0133-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0141-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0149-2020·2019-10-23
Xodus Medical Recalls Electrosurgical Tip Cleaners Due to Sterile Barrier Concerns
Xodus Medical Inc is recalling 464,040 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.
Product
Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0129-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0124-2020·2019-10-23
Integra LifeSciences Recalls Cerelink ICP Monitor Due to Reading Decline
Integra LifeSciences is recalling 189 Cerelink ICP Monitor units because they may show a progressive decline in intracranial pressure readings during use.
Product
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0128-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0134-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 19,350 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0136-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0130-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets with inline filters because fluid may leak out of the air vents. The recall covers 45,900 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0138-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents. The recall covers 6,400 units distributed in the U.S. and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling 521 units of Plum Microbore Infusion Sets because air vents on inline filters may leak fluid. The recall covers nationwide and international distribution.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0146-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling Sapphire Microbore Infusion Sets with Inline Filters due to a potential for fluid leakage out of air vents.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2020·2019-10-23
Medtronic Euphoria Balloon Catheters Recalled for Stylette Removal Difficulties
Medtronic is recalling Euphoria Rapid Exchange Balloon Dilatation Catheters because a slightly higher diameter stylette causes removal difficulties.
Product
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0143-2020·2019-10-23
ICU Medical Recalls Sapphire Microbore Infusion Sets Due to Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents. The product was distributed in the U.S. and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2020·2019-10-23
OrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk
OrthoPediatrics Corp is recalling 211 units of Adolescent attachment bolts used with the Pediatric Nailing Platform. The recall is due to potential interference between the bolt and nail, which may delay surgical procedures.
Product
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2020·2019-10-23
ICU Medical Recalls Sapphire Infusion Sets Due to Fluid Leakage Risk
ICU Medical is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filters. The recall covers 4,600 units distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0137-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Fluid Leakage Risk
ICU Medical Inc is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filters. The affected units were distributed nationwide and internationally.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2020·2019-10-23
ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.
Product
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2020·2019-10-23
Siemens Atellica CH 930 Analyzer Recalled for Erroneous Hemolysis and Lipemia Indices
Siemens Healthcare Diagnostics is recalling 1,125 Atellica CH 930 Analyzers worldwide due to software errors that may produce incorrect hemolysis and lipemia indices.
Product
Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0151-2020·2019-10-23
Xodus Medical Recalls Cautery Tip Cleaners Due to Sterile Barrier Concerns
Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.
Product
Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory
Category
Medical Device
Distribution
Distributed nationwide

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19201–19225 of 40124