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

18051–18075 of 40124

HighFDA (Devices)·Z-1235-2020·2020-02-26
Cardinal Health Recalls Presource Procedure Packs with Potential Sterility Issues
Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile due to improper environmental conditions during manufacturing.
Product
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2020·2020-02-26
Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns
Nobel Biocare is recalling Dense Bone Drills because a packaging defect may compromise sterility during shelf life.
Product
Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2020·2020-02-26
Siemens Luminos Agile Max X-ray System Recalled for Collision Risk
Siemens is recalling 475 Luminos Agile Max X-ray systems because a bypass key can override collision controls, creating a risk of collision with obstacles or persons.
Product
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1319-2020·2020-02-26
Nobel Biocare Recalls Implant Retrieval Instruments Due to Sterility Concerns
Nobel Biocare is recalling 423 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.
Product
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2020·2020-02-26
Philips CombiDiagnost PCF X-ray System Software Recall
Philips is recalling 131 CombiDiagnost PCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.
Product
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2020·2020-02-26
FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.
Product
Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1337-2020·2020-02-26
Siemens Luminos dRF Max Recalled for Software Bug Affecting Patient Images
Siemens Medical Solutions USA, Inc. is recalling 46 Luminos dRF Max digital radiography systems due to a software bug that may assign one image to two different patients, potentially affecting medical diagnosis.
Product
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1311-2020·2020-02-26
Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects
Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing defect may compromise sterility during shelf life.
Product
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2020·2020-02-26
Hitachi Medical Systems Recalls 18 Ultrasound Probes Due to Mis-Wiring
Hitachi Medical Systems America Inc is recalling 18 UST-2265-2 ultrasound probes due to potential mis-wiring that may cause decreased sensitivity and lower peak velocity readings.
Product
UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1233-2020·2020-02-26
Siemens Dimension Vista Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine reagent because it may produce falsely depressed results for patients taking phenindione.
Product
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1317-2020·2020-02-26
Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 197 implant retrieval instruments because a packaging defect may compromise sterility during shelf life.
Product
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2020·2020-02-26
Philips HeartStart FRx AED Recalled for Quality Standards Violation
Philips is recalling 44 HeartStart FRx AED units because their Printed Circuit Assemblies were not manufactured or repaired according to quality standards.
Product
Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1274-2020·2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Product
Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1301-2020·2020-02-26
Cardinal Health Recalls Presource Procedure Packs Due to Sterility Concerns
Cardinal Health is recalling Presource Procedure Packs containing AAMI Level 3 surgical gowns because they may not be sterile. This could increase the risk of surgical site infections.
Product
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2020·2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.
Product
Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1338-2020·2020-02-26
Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images
Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.
Product
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2020·2020-02-26
Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns
Nobel Biocare is recalling 8 units of tapered dental drills because a packaging sealing issue may compromise sterility during shelf life.
Product
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2020·2020-02-26
Siemens Recalls ADVIA Chemistry CardioPhase hsCRP Calibrator Due to Accuracy Drift
Siemens Healthcare Diagnostics is recalling 844 units of ADVIA Chemistry CardioPhase hsCRP Calibrator because accuracy has drifted from reference materials, causing high bias in quality control and patient sample recovery.
Product
ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1232-2020·2020-02-26
Siemens Dimension Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagent because it may produce falsely low results for patients taking phenindione.
Product
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1328-2020·2020-02-26
Philips CombiDiagnost GCF X-ray System Software Recall
Philips is recalling 116 CombiDiagnost GCF X-ray systems due to a software error that locks the table and an incorrectly installed thermos switch.
Product
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1231-2020·2020-02-26
Siemens Atellica CH Enzymatic Creatinine Reagent Recalled for Interference
Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagent due to potential falsely depressed results for patients on phenindione therapy.
Product
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1339-2020·2020-02-26
Siemens Ysio Max Radiographic System Recalled for Software Bug
Siemens Medical Solutions is recalling 507 Ysio Max radiographic systems because a software bug may assign one image to two different patients, potentially affecting medical diagnosis.
Product
Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f the whole body including: skull, chest, abdomen, and extremities and may be used on…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1275-2020·2020-02-26
Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.
Product
Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2020·2020-02-26
Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
Product
Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2020·2020-02-26
Nobel Biocare Recalls Tapered Drills Due to Sterility Concerns
Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.
Product
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

18051–18075 of 40124