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

18026–18050 of 27647

SevereFDA (Devices)·Z-1843-2018·2018-05-23
Medtronic Recalls Bariatric Surgical Kits Due to Missing Staple Sled Component
Medtronic is recalling 169,775 bariatric surgical kits worldwide because a missing sled component may prevent staple formation, risking bleeding or leakage.
Product
(1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNA (2) KITBAR021- BARIATRIC KIT X1 Item Code:KITBAR021- BARIATRIC KIT X0 (3)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Code: SGGLOGX1 ZESTAW DO BARIATRII (4)BOX SGGLOGX1 ZESTAW DO BARIATRII Item Coder:SGGLOGX1 ZESTAW DO…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1840-2018·2018-05-23
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
(1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143, KITDE0143 BYPASS BOX) (2) BOX KITDE0154 BYPASS KH NORDWEST (Item Number: KITDE0154, KITDE0154 BYPASS KH NORDWEST Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1865-2018·2018-05-23
Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
BOX VMIN ZESTAW DO VATS PODSTAWOWY 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
SevereFDA (Devices)·Z-1825-2018·2018-05-23
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, leading to bleeding or leakage.
Product
BOX KIT1095V KIT OBESITAS (Item Code KIT1095V) 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-1821-2018·2018-05-23
Medtronic Recalls Endo GIA Stapler Reloads Due to Missing Sled Component
Medtronic is recalling 171,271 Endo GIA 30mm stapler reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the…
Category
Medical Device
Distribution
Distributed nationwide
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

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18026–18050 of 27647