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

25251–25275 of 27722

SevereFDA (Devices)·Z-1301-2014·2014-04-02
BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk
BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.
Product
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1272-2014·2014-04-02
Siemens AXIOM Artis Systems Recalled for Potential Gantry Drop Risk
Siemens is recalling 37 AXIOM Artis angiography systems because a cooling unit defect may cause a system failure and gantry drop.
Product
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1275-2014·2014-04-02
Velocity Medical Solutions Recalls DICOM Export Format Software
Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.
Product
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2014·2014-04-02
Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect
Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.
Product
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1278-2014·2014-04-02
Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to reported gas leakage that may delay surgical procedures.
Product
5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1293-2014·2014-04-02
Teleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect
Teleflex Medical is recalling non-absorbable polypropylene sutures because they failed to meet minimum needle attachment strength requirements.
Product
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1284-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.
Product
5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1291-2014·2014-04-02
Teleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures
Teleflex Medical is recalling 32,271 units of non-absorbable polyamide surgical sutures because they failed to meet minimum needle attachment strength requirements.
Product
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1283-2014·2014-04-02
Teleflex Vista Optical Bladeless Laparoscopic Access Port Recalled for Gas Leakage
Teleflex Medical is recalling Vista Optical Bladeless Laparoscopic Access Ports because gas leakage can delay or prevent the completion of laparoscopic surgeries.
Product
5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1285-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices
Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1276-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because they may leak insufflation gas, potentially delaying or complicating laparoscopic surgeries.
Product
Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because complaints were received regarding leakage of insufflation gas, which can delay surgical procedures.
Product
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1287-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Port
Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Balloon Open Access Port due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1277-2014·2014-04-02
Teleflex Medical Recalls 10mm Weck Vista Cannula Due to Gas Leakage
Teleflex Medical is recalling 55,521 units of 10mm Weck Vista Cannula-only devices due to reported leakage of insufflation gas, which may delay laparoscopic surgeries.
Product
10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1296-2014·2014-04-02
Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect
Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.
Product
Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2014·2014-04-02
Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect
Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.
Product
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1281-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports due to reported gas leakage that may delay surgical procedures.
Product
Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2014·2014-04-02
Teleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect
Teleflex Medical is recalling non-absorbable poly(ethylene terephthalate) surgical sutures because they did not meet minimum needle attachment strength requirements.
Product
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1288-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1279-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage
Teleflex Medical is recalling 5/10 mm Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.
Product
5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2014·2014-04-02
BioCardia Recalls Morph AccessPro Steerable Introducers Due to Particulate Risk
BioCardia, Inc. is recalling Morph AccessPro Steerable Introducers because particulates in the inner lumen could cause an embolic event.
Product
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to reported gas leakage that may delay laparoscopic surgeries.
Product
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2014·2014-04-02
Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error
Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.
Product
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2014·2014-04-02
Teleflex Medical Recalls Polyglycolic Acid Sutures for Needle Attachment Defects
Teleflex Medical is recalling 32,271 units of absorbable polyglycolic acid sutures because they failed to meet minimum needle attachment strength requirements.
Product
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1282-2014·2014-04-02
Teleflex Medical Recalls 12mm Weck Vista Cannula Due to Gas Leakage
Teleflex Medical is recalling 12mm Weck Vista Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgical procedures.
Product
12mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Category
Medical Device
Distribution
Distributed nationwide

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25251–25275 of 27722