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 27500

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
HighFDA (Devices)·Z-0853-2020·2020-02-05
Vitreq Recalls VitreQ 27G Cannulas Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 27G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2020·2020-02-05
Vitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G Blunt Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2020·2020-02-05
Vitreq 23G Needles Recalled for Potential Sterility Compromise
Vitreq Bv is recalling VitreQ 23G needles because microscopic tears in the sterile pouch may compromise sterility.
Product
(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0920-2020·2020-02-05
Mindray BA-800M Chemistry Analyzer Recalled for Gas Spring Failure Risk
Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.
Product
BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0888-2020·2020-02-05
Haemonetics Recalls Cell Saver 5/5+ Fastpacks Due to Potential Bowl Cracks
Haemonetics is recalling Cell Saver 5/5+ Fastpacks because cracks in the bowl core may cause fluid trapping and incomplete washing.
Product
CS5/5+ Fastpacks, 125 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-0922-2020·2020-02-05
Roche Cobas infinity Software Recalled for Incorrect Alarm Mapping
Roche Diagnostics is recalling 20 Cobas infinity software modules due to incorrect alarm mapping. The software versions 2.4.1 through 2.5.4 are affected.
Product
Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0896-2020·2020-02-05
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 washing.
Product
CS Elite Fastpack, 125 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-0854-2020·2020-02-05
Vitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 20G VFI Cannulas because microscopic tears in the sterile pouch may compromise sterility.
Product
VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2020·2020-02-05
ROi CPS Recalls Custom Procedure Packs Containing Recalled Clearlink Devices
ROi CPS LLC is recalling 412 custom procedure packs containing Clearlink Continu-Flo devices that were previously recalled by Baxter Healthcare Corporation.
Product
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0917-2020·2020-02-05
Bard Conquest 40 PTA Dilation Catheter Recalled for Packaging Error
Bard Peripheral Vascular Inc. is recalling 286 units of Conquest 40 PTA Dilation Catheters because packaging incorrectly listed the balloon size, posing a risk of vessel injury.
Product
Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-0891-2020·2020-02-05
Haemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk
Haemonetics is recalling Cell Saver 5/5+ Bowl Kits because they may leak, trapping fluid and causing incomplete washing.
Product
Cell Saver¿5/5+ Bowl Kit (225 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-0871-2020·2020-02-05
Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure
Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts because the shaft end may fail to mate effectively with the broach.
Product
ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0901-2020·2020-02-05
Haemonetics Recalls Cell Saver Bowl Sets Due to Potential Leaks
Haemonetics is recalling Cell Saver bowl sets because cracks may cause leaks and incomplete blood washing.
Product
Japan CS Elite FASTPACK DISP. 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-0847-2020·2020-02-05
Vitreq 25G Blunt and Brush Needles Recalled for Sterility Risk
Vitreq Bv is recalling VitreQ 25G Blunt and Brush Needles because microscopic tears in the sterile pouch may compromise sterility.
Product
(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25.D52 GTIN: 8719214221188
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0841-2020·2020-01-29
KaVo Scan eXam X-Ray Imager Recalled for Power Supply Fire Risk
Palodex Group Oy is recalling KaVo Scan eXam X-ray imagers because plastic insulation degradation in the power supply may cause short circuits, heating, and smoke.
Product
KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0835-2020·2020-01-29
Polymer Technology Systems Recalls CardioChek Plus Analyzers Due to Battery Overheating Risk
Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause reverse contact and potential overheating.
Product
Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0842-2020·2020-01-29
Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk
Palodex Group Oy is recalling Instrumentarium Dental Express X-ray imagers because slow degradation of plastic insulation in the power supply unit may cause short circuits, heating, and smoke.
Product
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0830-2020·2020-01-29
Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Interference
Siemens is recalling ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.
Product
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Category
Medical Device
Distribution
Distributed nationwide

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14476–14500 of 27500