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 deaths or serious injuries are reported, 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

2876–2900 of 5111

SevereFDA (Devices)·Z-1977-2019·2019-07-24
FDA Recalls Advincula Delineator Uterine Manipulator Due to Cracking Risk
CooperSurgical is recalling 213 units of the Advincula Delineator Uterine Manipulator because the soft cup may crack during use, posing a risk of lacerations.
Product
Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH)
Category
Medical Device
Distribution
14 states
SevereFDA (Devices)·Z-1874-2019·2019-07-17
Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk
Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.
Product
HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and institutio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1923-2019·2019-07-17
Philips HeartStart MRx Recall Due to AC Power Module Failure Risk
Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.
Product
Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1899-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk
Siemens is recalling 131 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1896-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure
Siemens is recalling 120 Artis X-Ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1898-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Support Screw Failure
Siemens is recalling 12 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Potential Screw Failure
Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1895-2019·2019-07-10
Siemens Artis zee Ceiling X-Ray System Recall for Loose Screws
Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.
Product
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1894-2019·2019-07-10
Siemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure
Siemens is recalling 63 Artis zee X-ray systems because ceiling support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1904-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk
Siemens is recalling 11 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1900-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Potential Ceiling Mount Failure
Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury.
Product
Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1924-2019·2019-07-10
Draco Enzymatic Deep-Cleaning Pad Recalled for Bacterial Contamination
Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Stenotrophomonas lactiubi. The affected units were distributed to 13 US states.
Product
Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1905-2019·2019-07-10
Siemens Fluoroscopic X-Ray Systems Recalled for Potential Screw Failure
Siemens is recalling eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.
Product
Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1908-2019·2019-07-10
Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture
Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.
Product
REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1901-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled Due to Ceiling Mount Screw Failure Risk
Siemens is recalling two Artis Q zeego X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1897-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk
Siemens is recalling 29 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1945-2019·2019-07-10
Bio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes
Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.
Product
ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1903-2019·2019-07-10
Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure
Siemens is recalling 15 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.
Product
Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1385-2019·2019-07-03
Vyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution
Vyaire Medical is recalling enFlow Disposable Cartridges because testing showed aluminum elution during fluid warming. The recall covers 5,782,820 units distributed worldwide.
Product
enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1888-2019·2019-07-03
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1889-2019·2019-07-03
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk
Ethicon is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to a reported incidence of intraoperative bleeding.
Product
Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1757-2019·2019-06-26
Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters
Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.
Product
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in periphe
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1759-2019·2019-06-26
Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.
Product
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1831-2019·2019-06-26
FDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins
The FDA is recalling 3,113,280 units of EGIA45 CT AR MD THK REL surgical staplers because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
Product
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1829-2019·2019-06-26
Covidien EGIA 60 Articulating Medical Stapler Recall for Missing Pins
FDA is recalling 3,113,280 units of the EGIA 60 Articulating Medical Stapler due to missing pin components that may cause incomplete staple formation and serious surgical complications.
Product
EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
Category
Medical Device
Distribution
Distributed nationwide

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2876–2900 of 5111