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

2926–2950 of 5038

SevereFDA (Devices)·Z-1669-2019·2019-06-05
Maquet Cardiovascular Recalls Custom Tubing Sets for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge- (1) Material :701067370R01 BO-TOP 38803 OPEN HEART PACK W (2) Material: 701067370R02 BO-TOP 38803 OPEN HEART PACK W (3) Material: 701067370R03 BO-TOP 38803 OPEN HEART PACK W
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1651-2019·2019-06-05
Maquet Getinge Rapid Response Universal Packs Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling Rapid Response Universal Packs because a design flaw may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge- BO-TOP 13901 Rapid Response Universal Pk Material: 701054874R01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1526-2019·2019-06-05
Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge-BO-TOP 20705 SMALL PATIENT 1/4 Material: 701053486
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1519-2019·2019-06-05
Maquet Custom Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design feature may prevent sterilization gas from reaching all fluid paths.
Product
Maquet Getinge-BEQ-TOP 27901 SMALL PATIENT CI Material:701052287
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1515-2019·2019-06-05
Maquet Getinge ECC Tubing Sets Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Custom Tubing Sets for Extracorporeal Circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge-BEQ-TOP 22702 ECC W/HMOD 30000 Material: 701051179
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1633-2019·2019-06-05
Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge-BEQ-TOP 22600 ECC QUADROX iD 3/8 Material:701049440R02
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1666-2019·2019-06-05
Maquet Getinge NICU ECC Pack Recall Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling NICU ECC Packs because a design feature may prevent sterilization gas from reaching all fluid paths, compromising sterility.
Product
Maquet Getinge- BEQ-TOP 39202 NICU ECC PACK Material: 701067313R01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1544-2019·2019-06-05
Maquet Getinge-T 8028 Pressure Pigtail Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Pressure Pigtail devices because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Product
Maquet Getinge-T 8028 PRESSURE PIGTAIL 4" Material: 701055993
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1575-2019·2019-06-05
Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge-BEQ-T 46500 PRIME PACK Material:701065823
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1507-2019·2019-06-05
Maquet Getinge-BEQ-TOP 5900 Custom Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design flaw may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge-BEQ-TOP 5900 3/8 Quadrox iD Pack w/BB Material: 701050228
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1670-2019·2019-06-05
Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization gas flow, compromising sterility.
Product
Maquet Getinge BEQ-T 3501 LVAD 3/8" Material: 701068008R01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1652-2019·2019-06-05
Maquet Getinge E-Circuit Bioline Heparin Tubing Sets Recalled for Sterility Concerns
Maquet Cardiovascular is recalling specific batches of BEQ-TOP 37200 E-Circuit Bioline Heparin tubing sets because a design feature may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge- BEQ-TOP 37200 E-Circuit Bioline Heparin Material: 701055388R01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1511-2019·2019-06-05
Maquet Getinge-BEQ-TOP Circulatory Circuits Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific batches of Maquet Getinge-BEQ-TOP 15704 Circulatory Circuits because a design feature may prevent proper sterilization of the stopcock ports.
Product
Maquet Getinge-BEQ-TOP 15704 Circulatory Circuit 3/8" Material: 701050859
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1615-2019·2019-06-05
Maquet Cardiovascular Recalls Custom Tubing Sets for Extracorporeal Circulation
Maquet Cardiovascular is recalling custom tubing sets for extracorporeal circulation because a design flaw may prevent sterilization gas from reaching all parts of the device.
Product
Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1376-2019·2019-06-05
Terumo Portico Solo Re-Collapsible Access System Recalled for Tip Dislodgement
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
Product
Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1536-2019·2019-06-05
Maquet Getinge-T Sample Manifold Recalled Due to Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific Sample Manifolds because a design feature may prevent sterilization gas from reaching all fluid paths, potentially compromising sterility.
Product
Maquet Getinge-T 22706 SAMPLE MANIFOLD Material:701054912
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1687-2019·2019-06-05
Abbott MitraClip XTR Clip Delivery System Recalled for Malfunction
Abbott Vascular is recalling the MitraClip XTR Clip Delivery System because clips may open or become nonfunctional during implantation, requiring additional surgery.
Product
Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
Category
Medical Device
Distribution
49 states
SevereFDA (Devices)·Z-1637-2019·2019-06-05
Maquet Getinge Custom Tubing Sets Recalled for Sterility Assurance Concerns
Maquet Cardiovascular is recalling specific custom tubing sets for extracorporeal circulation because a design feature may prevent proper sterilization, potentially compromising sterility.
Product
Maquet Getinge- BEQ-TOP 5900 TCH 3/8 Quadrox-iD Pack Material:701050228R01
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1364-2019·2019-05-29
Ortho-Clinical VITROS XT 7600 System Recalled for Potential Sample Dispensing Errors
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated Systems because sample fluid may be dispensed to incorrect positions, potentially causing erroneous assay results.
Product
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1275-2019·2019-05-22
Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1273-2019·2019-05-22
Ethicon Endo-Surgery Recalls Endoscopic Curved Intraluminal Staplers
Ethicon Endo-Surgery is recalling 434,614 endoscopic curved intraluminal staplers because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1270-2019·2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Curved Intraluminal Staplers (Model CDH33A) because they may have an insufficient firing stroke to break the washer and form staples.
Product
Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1276-2019·2019-05-22
Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery Inc is recalling 434,614 Straight Intraluminal Staplers (Model SDH25A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1268-2019·2019-05-22
Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling Curved Intraluminal Staplers, Model CDH25A, because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1278-2019·2019-05-22
Ethicon Endo-Surgery Recalls Straight Intraluminal Staplers Due to Firing Defect
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH33A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
Category
Medical Device
Distribution
Distributed nationwide

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2926–2950 of 5038