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

17976–18000 of 27534

SevereFDA (Devices)·Z-1859-2018·2018-05-23
Medtronic Endo GIA Stapler Sleeves Recalled for Missing Sled Component
Medtronic is recalling 169,775 Endo GIA stapler sleeves worldwide due to a missing sled component that may prevent staple formation, risking bleeding or leakage.
Product
(1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2018·2018-05-23
Medtronic Endo GIA Stapler Loading Units Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, risking bleeding or leakage.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1828-2018·2018-05-23
Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Universal staplers because a missing sled component may prevent staple formation, risking bleeding or leakage.
Product
BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1866-2018·2018-05-23
Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
BOX VWR ZESTAW DO VATS KLIN Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1820-2018·2018-05-23
Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1822-2018·2018-05-23
Medtronic Endo GIA Stapler Reloads Recalled for Missing Sled Component
Medtronic is recalling Endo GIA 30mm stapler reloads because a missing sled component may cause staple failure, leading to bleeding or leakage.
Product
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1837-2018·2018-05-23
Medtronic Endo GIA Universal Bypass Kits Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA Universal Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1849-2018·2018-05-23
Medtronic Recalls Bariatric Staplers Due to Missing Sled Component
Medtronic is recalling specific bariatric stapler kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
(1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199) (2) BOX PST03403 ALTERNATIVE APPENDIX KIT (Item Number: PST03403) (3) BOX PST03533 KIT APP STAPLER (Item Number: PST03403) Product Usage: The Endo GIA universal and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1832-2018·2018-05-23
COVIDIEN Medtronic Recalls Endo GIA Stapler Kits Due to Missing Sled
COVIDIEN Medtronic is recalling Endo GIA universal stapler kits because a missing sled component may prevent proper staple deployment, risking bleeding or leakage.
Product
BOX KIT00713 KIT BY PASS Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1839-2018·2018-05-23
Medtronic Recalls Bypass Kits Due to Missing Stapler Component
Medtronic is recalling 171,271 Endo GIA Bypass Kits because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1831-2018·2018-05-23
Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
KIT00486R OBESIDAD D. WORWARLD 2 X1 (Item Number KIT00486R) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1834-2018·2018-05-23
Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
BOX KIT1171C KIT LAP CYSTECTOMY Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2018·2018-05-23
Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA universal staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2018·2018-05-23
Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA Universal and Universal XL staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Product
BOX PST03699 KIT APP MED ALTERNATIV STAP Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1805-2018·2018-05-23
Zimmer Biomet Recalls Persona Stemmed Tibial Provisional Instruments
Zimmer Biomet is recalling 842 Persona Stemmed Tibial Provisional instruments due to potential cracks in the raw material that could compromise cleanliness.
Product
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2018·2018-05-23
Tosoh HbA1c Pretreatment Solution Recalled for Potential Inaccurate Test Results
Tosoh Bioscience Inc is recalling HbA1c Pretreatment Solution because it may cause erroneously elevated or decreased patient test results.
Product
Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1808-2018·2018-05-23
Zimmer Biomet Recalls Persona Cemented Tibial Plate Due to Cracks
Zimmer Biomet is recalling 842 Persona Cemented Tibial Plate units because potential cracks in the raw material could compromise the cleanliness of the instruments.
Product
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2018·2018-05-23
Richard Wolf Tube Set for TEM Recalled for Potential Tube Mixing
Richard Wolf GmbH is recalling 1,710 units of the Tube Set for TEM (Ref 4170.801) because tube ends may be mixed up.
Product
RICHARD WOLF TUBE SET FOR TEM, REF 4170.801. Used for the transanal endoscopic microsurgery.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1871-2018·2018-05-23
Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes
Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
Product
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2018·2018-05-23
Draeger Infinity Acute Care System Recalled for Software Anomaly
Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.
Product
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1877-2018·2018-05-23
Micro-Tech Trident Endoscopic Ultrasonic Biopsy Needle Recall
Micro-Tech is recalling 40 Trident Endoscopic Ultrasonic Biopsy Needles because they may break in the human body, potentially causing injury.
Product
Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1872-2018·2018-05-23
Kelyniam Custom Skull Implant Recall for Unvalidated Design Changes
Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Product
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2018·2018-05-23
Visaris Diagnostic X-Ray Systems Recalled for Tube Arm Suspension Failure Risk
Visaris DOO is recalling 22 diagnostic X-ray systems worldwide due to a potential failure of the tube arm suspension that could cause an uncontrollable descent and patient injury.
Product
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1701-2018·2018-05-23
Ev3 MindFrame Capture Devices Recalled for Potential Wire Separation
Micro Therapeutics is recalling MindFrame Capture LP Revascularization Devices because they may partially detach from the delivery wire.
Product
MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1746-2018·2018-05-23
Siemens Recalls CT Scanner Software for Radiation Risk
Siemens Medical Solutions is recalling 134 SOMATOM Definition Edge CT scanners due to a software issue that may cause unnecessary radiation exposure.
Product
SOMATOM Definition Edge (Model 10590000) Computed tomography x-ray diagnostic system
Category
Medical Device
Distribution
3 states

How to read this listing

Filters

17976–18000 of 27534