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 5038

SevereFDA (Devices)·Z-1814-2018·2018-05-23
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, risking bleeding or leakage.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) 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, t
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-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 tissue
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-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-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-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-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 t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1816-2018·2018-05-23
COVIDIEN Recalls Endo GIA Stapler Loading Units Due to Missing Sled Component
COVIDIEN MEDTRONIC is recalling 171,271 Endo GIA Universal Articulating Loading Units because a missing sled component may prevent proper staple deployment, risking bleeding or leakage during surgery.
Product
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) 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-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-1710-2018·2018-05-16
Datascope recalls Better Bladder device in custom tubing kits
Datascope is recalling the Better Bladder device in custom tubing kits because seal separation may allow air to enter the housing, potentially causing a drop in ECMO circuit blood flow.
Product
BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
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-1712-2018·2018-05-16
Datascope Better Bladder Device Recalled Due to Seal Separation Risk
Datascope Corporation is recalling the Better Bladder device found in custom tubing kits. A seal defect may allow air entry, causing balloon collapse and reduced blood flow in ECMO circuits.
Product
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1728-2018·2018-05-16
Datascope Recalls Custom Tubing Kits Due to Potential Balloon Collapse
Datascope Corporation is recalling BEQ-TOP 22301 Custom Tubing Kits because seal separation may allow air to enter the housing, causing the balloon to collapse and reducing blood flow.
Product
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
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-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-1714-2018·2018-05-16
Datascope recalls Better Bladder device due to seal separation risk
Datascope is recalling the Better Bladder device because seal separation may allow air to enter the housing, potentially collapsing the balloon and reducing ECMO blood flow.
Product
BEQ-TOP 22701, Catalog No. 701050790
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
SevereFDA (Devices)·Z-1484-2018·2018-05-16
Draeger Fabius Tiro M Anesthesia Machine Recalled for Ventilator Failure Risk
Draeger Medical is recalling one Fabius Tiro M anesthesia machine because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1483-2018·2018-05-16
Draeger Fabius Tiro Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 26 Fabius Tiro anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted ga
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1482-2018·2018-05-16
Draeger Fabius GS Premium Anesthesia Machines Recalled for Ventilation Failure Risk
Draeger Medical is recalling 27 Fabius GS Premium anesthesia machines because automatic ventilation may fail if motor position detection is disturbed.
Product
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally moun
Category
Medical Device
Distribution
Distributed nationwide
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-1739-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
Zimmer Biomet is recalling 107 Gentle Threads interference screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, potentially leading to infection.
Product
Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1708-2018·2018-05-16
Datascope Recalls Adult ECC Pack Due to Seal Separation Risk
Datascope Corporation is recalling three units of the Adult ECC Pack BEQ-TOP 22300 because seal separation may allow air into the housing, potentially collapsing the balloon and reducing blood flow.
Product
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Category
Medical Device
Distribution
13 states

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3376–3400 of 5038