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

20351–20375 of 27647

HighFDA (Devices)·Z-0892-2017·2016-12-28
Medtronic Recalls PowerCross .018 OTW PTA Dilatation Catheters
Medtronic is recalling 315 units of the PowerCross .018 OTW PTA Dilatation Catheter due to a manufacturing defect causing the balloon to fail to inflate or deflate properly.
Product
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0819-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragment
Oscor, Inc. is recalling 45 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0816-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Liner Fragmentation
Oscor, Inc. is recalling Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner may come out during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0900-2017·2016-12-28
Exactech Recalls Equinoxe Reverse Shoulder Screw Kits Due to Disengaged Heads
Exactech, Inc. is recalling 2,278 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kits because disengaged screw heads may not be retained in the screwdriver.
Product
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled Due to Liner Fragmentation
Oscor, Inc. is recalling 55 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0893-2017·2016-12-28
Ansell Recalls Gammex Surgical Gloves Due to Latex Contamination
Ansell Healthcare Products is recalling 15 cases of Gammex Non-Latex Surgical Gloves because they incorrectly contained natural rubber latex gloves.
Product
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0805-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 110 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0792-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 30 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0796-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 61 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion. The product was distributed in the US and internationally.
Product
OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0815-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Fragment Release
Oscor, Inc. is recalling 59 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0885-2017·2016-12-28
Siemens IMMULITE 2000 PSA Assay Recalled for Hook Effect Performance Issues
Siemens Healthcare Diagnostics is recalling IMMULITE 2000 PSA assays because they do not meet the High-dose Hook Effect expectations stated in the Instructions for Use.
Product
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0791-2017·2016-12-28
Oscor Medical Sheath Recalled for Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 87 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0775-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 996 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0804-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 124 units of the Adelante Breezeway 10F sheath because a fragment of the inner liner detached during insertion. The product was distributed worldwide.
Product
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0817-2017·2016-12-28
Oscor Recalls Medtronic Arrive Braided Transseptal Sheaths Due to Liner Fragmentation
Oscor, Inc. is recalling 991 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner detached during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0808-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 33 units of the Adelante Breezway 10F Straight sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0777-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Detachment Risk
AngioDynamics is recalling 7 boxes of Stiffened Micro-Introducer Kits because the rotating luer on the included sheath/dilator components may detach from the hub during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0798-2017·2016-12-28
Oscor Medical Sheath Recall Due to Inner Liner Fragmentation During Insertion
Oscor, Inc. is recalling 26 units of the Adelante Breezeway 8F Straight sheath because a fragment of the inner liner detached during insertion. The defect poses a risk of foreign body introduction into the patient.
Product
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0814-2017·2016-12-28
Medtronic Arrive Braided Transseptal Sheath Recalled for Inner Liner Fragmentation
Oscor, Inc. is recalling 186 units of Medtronic Arrive Braided Transseptal Sheaths because a fragment of the inner liner was found during insertion.
Product
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0789-2017·2016-12-28
Smiths Medical Recalls Acuvance 2 Safety Catheters Due to Valve Defects
Smiths Medical is recalling 26,750 Acuvance 2 Safety Catheters because some devices have missing or incorrectly positioned side port valves.
Product
Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0786-2017·2016-12-28
AbbVie Recalls 20 FR PEG Kits Due to Disconnection Reports
AbbVie is issuing an urgent field correction for 20 FR PEG Kits due to increased reports of tube disconnections from Y-connectors.
Product
AbbVie PEG Kit 20 FR
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0773-2017·2016-12-28
AngioDynamics Recalls Stiffened Micro-Introducer Kits Due to Component Defect
AngioDynamics is recalling 80 boxes of Stiffened Micro-Introducer Kits because a component may detach during use.
Product
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0800-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 22 units of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0801-2017·2016-12-28
Oscor Medical Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling specific lots of the Adelante Breezeway sheath because a fragment of the inner liner detached during insertion.
Product
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0884-2017·2016-12-28
Siemens IMMULITE PSA Assay Recalled for High-Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling IMMULITE PSA assays because they do not meet the high-dose hook effect expectations stated in the Instructions for Use.
Product
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics…
Category
Medical Device
Distribution
Distributed nationwide

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