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

14476–14500 of 27471

HighFDA (Devices)·Z-0894-2020·2020-02-05
Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.
Product
CS Elite Fastpack, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2020·2020-02-05
Haemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks
Haemonetics is recalling CS5/5+ Bowl Kits because potential leaks may trap fluid, causing device errors and incomplete washing.
Product
CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0903-2020·2020-02-05
Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Leaks
Haemonetics is recalling Cell Saver Elite sets because potential leaks in the bowl core may cause fluid trapping and incomplete washing.
Product
JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0889-2020·2020-02-05
Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Leaks
Haemonetics is recalling 1,340 units of Cell Saver 5/5+ Fastpacks because potential leaks in the inner core may cause fluid trapping and incomplete washing.
Product
CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2020·2020-02-05
Energetiq EQ-400 Light Source Recalled for Safety Interlock Failure
Energetiq Technology is recalling 15 EQ-400 light sources because a safety interlock may fail to shut down the system if the laser collimator is removed.
Product
EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0887-2020·2020-02-05
Haemonetics Recalls Cell Saver Bowl Sets Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because they may leak, trapping fluid and causing incomplete washing.
Product
High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2020·2020-02-05
Haemonetics Recalls CS5/5+ Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling CS5/5+ Fastpacks because cracks in the bowl core may trap fluid, causing device errors and incomplete washing.
Product
CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0893-2020·2020-02-05
Haemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks
Haemonetics is recalling CS Elite Processing Sets (125 ml) because cracks in the bowl core may cause fluid trapping and incomplete blood washing.
Product
CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2020·2020-02-05
Haemonetics Recalls CS Elite Fastpack Autotransfusion Devices Due to Leak Risk
Haemonetics is recalling CS Elite Fastpack autotransfusion devices because cracks in the bowl core may cause leaks and incomplete blood washing.
Product
CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2020·2020-02-05
Vitreq Recalls VitreQ 23G Injection Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 23G PFC Injection Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0850-2020·2020-02-05
Vitreq Recalls VitreQ 25G Injection Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G PFC Injection Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2020·2020-02-05
Beckman Coulter Recalls iChemVELOCITY Urine Chemistry Systems Due to Data Errors
Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because they may report duplicate specimen IDs with conflicting patient data and results.
Product
iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem¿ VELOCITY Urine Chemistry Strips.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0857-2020·2020-02-05
Vitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 23G Pick Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0866-2020·2020-02-05
RayStation Treatment Planning Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation software due to defects that may cause incorrect dose calculations during treatment planning.
Product
RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2020·2020-02-05
Johnson & Johnson Recalls Healon GV PRO Ophthalmic Viscosurgical Devices
Johnson & Johnson is recalling Healon GV PRO ophthalmic viscosurgical devices because they may be difficult to remove from the eye, potentially causing increased pressure or equipment clogging.
Product
Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0869-2020·2020-02-05
LivaNova Recalls Cyberonics VNS Therapy AspireSR Generators for Battery Depletion
LivaNova is recalling 745 Cyberonics VNS Therapy AspireSR Model 106 generators due to electrical leakage causing premature battery depletion.
Product
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2020·2020-02-05
Haemonetics Recalls Cell Saver 5/5+ and Elite Bowl Sets Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ and Elite bowl sets because potential leaks may trap fluid, causing incomplete washing of recovered blood.
Product
JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0914-2020·2020-02-05
Beckman Coulter iQ200 Urine Analyzer Recalled for Duplicate Specimen ID Errors
Beckman Coulter is recalling iQ200 Series Urine Microscopy Analyzers because they may report duplicate Specimen IDs with different patient results.
Product
iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 700-3370, B48999, C10683, C10684 - Product Usage: device used to automate the complete urinalysis…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0904-2020·2020-02-05
Haemonetics Recalls Cell Saver Elite Sets Due to Potential Bowl Cracks
Haemonetics is recalling Cell Saver Elite sets because cracks in the bowl core may trap fluid, causing incomplete washing of recovered blood.
Product
JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2020·2020-02-05
Haemonetics Recalls Cell Saver Elite Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling Cell Saver Elite Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete blood washing.
Product
JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0856-2020·2020-02-05
Vitreq Bv Recalls VitreQ 25G Silicone Tipped Cannula Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G Silicone Tipped Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0858-2020·2020-02-05
Vitreq Bv Recalls VitreQ 25G Pick Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G Pick Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2020·2020-02-05
Haemonetics Recalls Japan Disp Sets Due to Potential Bowl Cracks
Haemonetics is recalling specific Japan Disp Sets for Cell Saver systems due to potential bowl cracks that may cause leaks and incomplete blood washing.
Product
JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. The recovered blood is processed by a centrifugation and washing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0906-2020·2020-02-05
Haemonetics Recalls Japan DISP SETs Due to Potential Bowl Cracks
Haemonetics is recalling 1,584 Japan DISP SETs because cracks in the bowl core may cause leaks and incomplete washing.
Product
Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0861-2020·2020-02-05
Vitreq 27G Blunt Needles Recalled for Potential Sterility Compromise
Vitreq Bv is recalling VitreQ 27G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
Category
Medical Device
Distribution
Distributed nationwide

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14476–14500 of 27471