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

36151–36175 of 40449

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
HighFDA (Devices)·Z-1289-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.
Product
5/10/12 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-1304-2014·2014-04-02
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 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1306-2014·2014-04-02
Abbott i-STAT G3+ Cartridge Recall for Inaccurate Blood Gas Results
Abbott Point of Care is recalling i-STAT G3+ Cartridges (Lot N13183) because they may produce incorrectly elevated PCO2 and depressed pH results.
Product
i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1290-2014·2014-04-02
Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports
Teleflex Medical is recalling 55,521 Weck Vista Universal Balloon Open Access Ports due to gas leakage that may delay laparoscopic surgeries.
Product
5/10/12 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-1274-2014·2014-04-02
Synthes Ulna Osteotomy System Drill Template and Saw Guide Recall
Synthes, Inc. is recalling 343 Drill Templates and Saw Guides for the Ulna Osteotomy System due to potential mechanical failure of connecting screws or K-wires.
Product
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2014·2014-04-02
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 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1202-2014·2014-04-02
Siemens Artis Q X-ray Systems Recalled for Potential Tube Breakdown
Siemens is recalling 19 Artis Q and Artis Q biplane systems because a breakdown of the x-ray tube could result in loss of x-ray imaging during clinical operation.
Product
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1299-2014·2014-04-02
Bio-Rad D-10 Hemoglobin Testing System Software Recall
Bio-Rad is recalling D-10 Hemoglobin Testing Systems because the software may occasionally generate duplicate results with incorrect sample identifiers.
Product
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2014·2014-04-02
Bard Access Systems Recalls PowerPort Slim Implantable Ports Due to Labeling Error
Bard Access Systems is recalling 777 PowerPort Slim Implantable Ports because the labels incorrectly state they contain silicone suture plugs, when some units do not.
Product
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1273-2014·2014-04-02
Spacelabs Recalls G2 Clinical Access Software CDs Due to Incorrect Programs
Spacelabs Healthcare is voluntarily recalling G2 Clinical Access Software CDs because they contain incorrect programs, preventing customers from installing the software.
Product
Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1268-2014·2014-04-02
AMS Uric Acid Test Kits Recalled for Regulatory Violations
AMS Diagnostics is recalling 13 Uric Acid test kits because they were marketed outside FDA 510(k) requirements.
Product
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1269-2014·2014-04-02
AMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements
AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.
Product
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1267-2014·2014-04-02
AMS BUN Urea Nitrogen Kits Recalled for Marketing Violations
AMS Diagnostics is recalling 167 BUN Urea Nitrogen kits because they were marketed outside FDA 510(k) requirements.
Product
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1270-2014·2014-04-02
Lin-Zhi Norbuprenorphine Calibrator Recalled for Quality Control Failure
Lin-Zhi International is recalling Norbuprenorphine cutoff calibrators because they failed quality control testing. The product is used for in vitro diagnostic calibration.
Product
Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; IVD - for in vitro diagnostic use only; Lin-Zhi International Sunnyvale, CA The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-1297-2014·2014-04-02
TriVascular Ovation Prime Abdominal Stent Graft System Instructions for Use Update
TriVascular, Inc. is notifying European physician users of the Ovation Prime Abdominal Stent Graft System about changes to the Instructions for Use.
Product
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic…
Category
Medical Device
Distribution
0 states

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36151–36175 of 40449