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

3376–3400 of 5111

SevereFDA (Devices)·Z-1826-2018·2018-05-23
Medtronic Endo GIA Universal Staplers Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA Universal and Universal XL staplers worldwide due to a missing sled component that may cause staple line failure, bleeding, or leakage.
Product
(1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS) (2) BOX 1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0) (3) BOX BOX1073076GASB0 BBR STVEIT GASTRIC B (Item Code BOX1073076GASB0 BBR STVEIT GASTRIC B) Product Usage:
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 End
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1842-2018·2018-05-23
Medtronic Endo GIA Stapler Kits Recalled for Missing Sled Component
Medtronic is recalling 171,271 Endo GIA stapler kits worldwide because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Product
(1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titan
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1823-2018·2018-05-23
Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
Medtronic is recalling specific Endo GIA vascular reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.
Product
Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) 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-1862-2018·2018-05-23
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 TGGLOGOWX1 DO TOTAL GASTRECTOMIII 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 deter
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, tri
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1815-2018·2018-05-23
Medtronic Recalls Endo GIA Stapler Loading Units Due to 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, leading to bleeding or leakage.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) 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-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
SevereFDA (Devices)·Z-1852-2018·2018-05-23
Medtronic Endo GIA Staplers Recalled for Missing Sled Component
Medtronic is recalling Endo GIA staplers because a missing sled component may prevent staple formation, leading to bleeding or leakage.
Product
BOX PST03533 KIT APP STAPLER 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-1830-2018·2018-05-23
COVIDIEN Medtronic Recalls Endo GIA Staplers for Missing Sled Component
COVIDIEN Medtronic is recalling approximately 171,271 Endo GIA universal staplers because a missing sled component may prevent proper staple deployment. This defect can lead to bleeding or leakage of luminal contents during surgery.
Product
(1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMII (Item Number HEMIGX1 ZESTAW DO HEMICOLECTOMII) (2) BOX LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI (item number: LAPPH ZASTAW DO PRAWEJ HEMIKOLEKTOMI Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place t
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-1848-2018·2018-05-23
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 MGBGLOGX1 ZESTAW MINI GASTRIC BYPASS 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 de
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, triple-sta
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1838-2018·2018-05-23
COVIDIEN Medtronic Recalls VATS Lobectomy Kits Due to Missing Sled Component
COVIDIEN Medtronic is recalling 171,271 VATS lobectomy kits because the device may be missing a sled component. This defect can cause failure to form a staple line, leading to bleeding or leakage during surgery.
Product
(1)KIT4184 APEN LOBECTOMY KIT X0 Item Number: KIT4184 APEN LOBECTOMY KIT XO (2) BOX VATSLOB11 ZESTAW DO VATS LOBECTOMII (Item Number: VATSLOB11, VATSLOB11 ZESTAW DO VATS LOBECTOMII Product Usage: The Endo GIA universal and Endo GIA universal XL staplers
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 row
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-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 b
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 sta
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2018·2018-05-16
Datascope recalls custom pediatric ECMO tubing kits due to seal defect
Datascope is recalling two custom pediatric ECMO tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow.
Product
BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 709000078
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1731-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 11 custom tubing kits containing the Better Bladder device due to a seal defect that may cause balloon collapse and reduced blood flow.
Product
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1717-2018·2018-05-16
Datascope Recalls Better Bladder Devices in Custom Tubing Kits
Datascope is recalling specific custom tubing kits because the Better Bladder device may fail, potentially reducing blood flow in ECMO circuits.
Product
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1625-2018·2018-05-16
Boston Scientific Recalls Pinnacle Posterior PFR Kits Due to Suture Breakage Risk
Boston Scientific is recalling 24 units of Pinnacle Posterior PFR Kits because the Capio sutures may break or detach.
Product
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1729-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope Corporation is recalling specific custom tubing kits because a seal defect may cause the balloon to collapse, potentially reducing blood flow in ECMO circuits.
Product
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1722-2018·2018-05-16
Datascope Better Bladder Custom Tubing Kit Recalled for Seal Separation
Datascope Corporation is recalling Better Bladder custom tubing kits because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.
Product
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1724-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling 18 custom tubing kits because a seal defect may allow air to enter the device, potentially causing a drop in ECMO blood flow.
Product
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Category
Medical Device
Distribution
13 states

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