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

21651–21675 of 40299

ModerateFDA (Devices)·Z-0592-2019·2018-12-19
Philips IntelliVue MX40 Patient Monitor Speaker Volume Recall
Philips is recalling IntelliVue MX40 patient monitors because the speaker volume may be diminished or inaudible at altitudes above 4,500 feet.
Product
IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0566-2019·2018-12-19
CIVCO Recalls SonoSite Needle Guide Brackets Due to Labeling Defects
CIVCO Medical Instruments is recalling 297 boxes of SonoSite Needle Guide Brackets because some units lack required product labeling.
Product
SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0570-2019·2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 66 boxes of Needle Guide Starter Kits because some brackets lack required product labeling. The recall covers units distributed globally.
Product
CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0594-2019·2018-12-19
Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
Product
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0573-2019·2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 20 boxes of Needle Guide Starter Kits due to missing product labeling. The voluntary recall covers units distributed in the US and 40 foreign countries.
Product
CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0574-2019·2018-12-19
CIVCO Needle Guide Bracket Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 49 boxes of Needle Guide Brackets because some units lack required product labeling.
Product
CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0602-2019·2018-12-19
Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear
Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.
Product
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0567-2019·2018-12-19
CIVCO Recalls SonoSite FUJIFILM Needle Guide Brackets for Labeling Issues
CIVCO Medical Instruments is recalling 115 boxes of SonoSite FUJIFILM Needle Guide Brackets due to missing product labeling. The recall covers units distributed in the US and 40 foreign countries.
Product
SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for:
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0569-2019·2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Labeling Defects
CIVCO Medical Instruments is recalling 234 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Product
CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0590-2019·2018-12-19
Zimmer Biomet Recalls Orthopedic Salvage System Porous Stem Due to Labeling Error
Zimmer Biomet is recalling specific lots of the Orthopedic Salvage System Porous Stem because the Mini Humeral Stem may be mislabeled as the Bowed IM Stem.
Product
Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0599-2019·2018-12-19
Tosoh AIA-2000 and AIA-900 Analyzers Recalled for Incubator Slippage
Tosoh Bioscience is recalling AIA-2000 and AIA-900 analyzers because a timing belt issue can cause incubator slippage, leading to system errors and delays in patient test results.
Product
AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0568-2019·2018-12-19
CIVCO Needle Guide Starter Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 257 boxes of Needle Guide Starter Kits because some brackets lack required product labeling.
Product
CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0596-2019·2018-12-19
BioFlo PICC Recall Issued for Incorrect Expiration Date Labeling
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
Product
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0576-2019·2018-12-19
CIVCO Sales Demo Kit Recalled for Missing Product Labeling
CIVCO Medical Instruments is recalling 135 boxes of Sales Demo Kits because some inventory brackets no longer have product labeling.
Product
CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0597-2019·2018-12-19
COVIDIEN Recalls Salem Sump Stomach Tubes Due to Packaging Error
COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.
Product
Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0601-2019·2018-12-19
Tosoh Recalls Hemoglobin A1c Control Material Due to Potential Degradation
Tosoh Bioscience is recalling Hemoglobin A1c Control material due to potential degradation that may cause testing delays.
Product
Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0536-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0549-2019·2018-12-12
Invacare Hydraulic Patient Lifts Recalled for Potential Caster Separation
Invacare is recalling 73,703 hydraulic patient lifts because a mounting bolt may loosen, causing the caster to separate and the lift to tilt.
Product
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0463-2019·2018-12-12
GE Healthcare Recalls CARESCAPE R860 Inspiratory Safety Guards
GE Healthcare is recalling CARESCAPE R860 Inspiratory Safety Guards because they may disconnect from the breathing circuit, potentially causing loss of ventilation and hypoxia in patients.
Product
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0544-2019·2018-12-12
Philips Brilliance 40 CT Systems Recalled for Gantry Cover Separation Risk
Philips is recalling 6,343 Brilliance 40 CT systems nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.
Product
Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0533-2019·2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0539-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2019·2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0551-2019·2018-12-12
Capintec Recalls Captus 700 Thyroid Uptake Systems Due to Spring Arm Failure
Capintec Inc is recalling 65 Captus 700 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.
Product
Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2019·2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide

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21651–21675 of 40299