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

23876–23900 of 40175

HighFDA (Devices)·Z-1752-2018·2018-05-16
Cook Inc. Recalls Connecting Tubes Due to Potential Fluid Leakage
Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
Product
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1790-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because they may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1665-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians incorrectly documented that all final release tests were completed, when several were actually omitted.
Product
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2018·2018-05-16
DePuy Mitek Recalls Latarjet EXPERIENCE Sharp Curved Ostetome
DePuy Mitek is recalling 84 units of the Latarjet EXPERIENCE Sharp Curved Ostetome due to reports of the product loosening or coming unscrewed from the handle.
Product
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist in the management of reconstructive surgeries.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2018·2018-05-16
Synthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation
Synthes (USA) Products LLC is recalling 235 Sciatic Nerve Retractors due to a potential for microspores to form on the hollow handle, which could allow fluid entry.
Product
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1738-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issue
Zimmer Biomet is recalling 54 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. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliance
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1736-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
Zimmer Biomet is recalling 53 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may have compromised the sterile barrier, potentially leading to infection.
Product
Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1793-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1786-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 119 Jasper Vektor Class II Correction Appliances because the devices have broken in patients' mouths, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1624-2018·2018-05-16
Boston Scientific Recalls Pinnacle Anterior Apical Pelvic Floor Repair Kits
Boston Scientific is voluntarily recalling 34 Pinnacle Anterior Apical pelvic floor repair kits due to a Class II safety concern. The devices were distributed worldwide.
Product
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1727-2018·2018-05-16
Datascope recalls custom tubing kits due to seal separation risk
Datascope is recalling four custom tubing kits because a seal defect may allow air to enter the device, potentially reducing blood flow in ECMO circuits.
Product
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-1683-2018·2018-05-16
Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions fail to list biotin interference concentrations, potentially causing inaccurate test results.
Product
IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1788-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Product
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1617-2018·2018-05-16
Boston Scientific Recalls Capio SLIM Box 5 Sutures Due to Breakage Risk
Boston Scientific is recalling 60,538 units of Capio SLIM Box 5 sutures because they may break or detach during open surgery.
Product
Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1652-2018·2018-05-16
Siemens Dimension Glucose Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Glucose assays because they may produce inaccurate results when used with certain drugs.
Product
Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1697-2018·2018-05-16
Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change
Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.
Product
Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1633-2018·2018-05-16
Vygon Recalls PICC Insertion Kits Due to Sterility Risk
Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.
Product
PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2018·2018-05-16
Cook Inc. Recalls Connecting Tubes Due to Potential Leakage
Cook Inc. is recalling 304 connecting tubes because the cap-adapter assembly may not tighten adequately, potentially causing fluid leakage or air aspiration.
Product
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1777-2018·2018-05-16
Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks
Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.
Product
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1670-2018·2018-05-16
Siemens Dimension Sirolimus Reagent Cartridge Recalled for Biotin Interference
Siemens Healthcare Diagnostics is recalling Dimension Sirolimus reagent cartridges because biotin can interfere with test results, potentially affecting patient care.
Product
Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1669-2018·2018-05-16
Siemens Dimension Free Thyroxine Reagent Cartridge Recall for Labeling Error
Siemens is recalling Dimension Free Thyroxine reagent cartridges because the instructions for use incorrectly state the level at which biotin does not interfere.
Product
Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1658-2018·2018-05-16
Siemens Dimension Vista Glucose Assay Recalled for Drug Interference
Siemens is recalling Dimension Vista Glucose assays because they may produce inaccurate results when used with certain drugs.
Product
Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1668-2018·2018-05-16
Siemens Recalls Dimension TSHL Reagent Cartridges Due to Biotin Labeling Error
Siemens Healthcare Diagnostics is recalling Dimension TSHL reagent cartridges because the instructions for use incorrectly state the biotin concentration level at which interference does not occur.
Product
Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1646-2018·2018-05-16
Siemens ADVIA Ammonia Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling ADVIA Ammonia assays because sulfasalazine and sulfapyridine may cause inaccurate test results.
Product
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories)
Category
Medical Device
Distribution
3 states

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23876–23900 of 40175