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

23851–23875 of 40175

HighFDA (Devices)·Z-1751-2018·2018-05-16
Cook Inc. Recalls Connecting Tubes Due to Potential 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 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-1663-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recalled for Documentation Errors
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.
Product
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX 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-1702-2018·2018-05-16
Bard BrachySource Iodine-125 Radioactive Seeds Recalled for Dosage Mix-Up
Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.
Product
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). The I125 has a half-life of 59.6 days and decays by electron capture with the…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1762-2018·2018-05-16
Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions
Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.
Product
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1664-2018·2018-05-16
Baxter Sigma Spectrum Infusion Pump Recall Due to Testing Documentation Errors
Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.
Product
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL 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-1783-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 108 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. 610-500 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-1770-2018·2018-05-16
Bard Peripheral Vascular Recalls POWERPORT ClearVUE Catheters Due to Incorrect Instructions
Bard Peripheral Vascular Inc is recalling specific lots of POWERPORT ClearVUE catheters because the included Patient ID Card has incorrect port flushing instructions.
Product
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1684-2018·2018-05-16
Siemens Recalls Immulite Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling certain IMMULITE assays because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Product
IMMULITE ¿ /IMMULITE ¿ 1000 TG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1200-2018·2018-05-16
Siemens ACUSON SC2000 Ultrasound Systems Recalled for ECG Signal Interference
Siemens is recalling 229 ACUSON SC2000 ultrasound systems because electromagnetic interference from electrosurgical equipment may cause the ECG signal to flatline.
Product
ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1637-2018·2018-05-16
Vygon Recalls PICC Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.
Product
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1620-2018·2018-05-16
Boston Scientific Recalls Capio Sutures Due to Breakage Risk
Boston Scientific is recalling 4,144 units of Capio Standard Box 4 sutures because they may break or detach during surgery.
Product
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1741-2018·2018-05-16
Microline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns
Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.
Product
ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1791-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling five 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. 610-533Lused 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-1640-2018·2018-05-16
Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise
Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.
Product
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2018·2018-05-16
Zimmer Biomet Recalls Gentle Threads Interference Screws Due to Sterilization Issues
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. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2018·2018-05-16
Siemens Recalls IMMULITE Assays Due to Biotin Interference Risk
Siemens Healthcare Diagnostics is recalling specific IMMULITE assay lots because the instructions for use do not list the biotin concentration that causes interference, posing a risk of inaccurate test results.
Product
IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1655-2018·2018-05-16
Siemens Dimension Vista Ammonia Assay Recalled for Drug Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista Ammonia assays because they may produce inaccurate results when used with certain drugs.
Product
Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1641-2018·2018-05-16
Medtronic Prestige LP Cervical Disc Drill Guides Recalled for Breakage
Medtronic is recalling specific drill guides for the Prestige LP Cervical Disc System because they may cause drill bits to break during use.
Product
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable instruments are intended for the surgical implantation of the PRESTIGE LP…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2018·2018-05-16
Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration
Cook Inc. is recalling 554 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, HPCT8.8-100-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…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1635-2018·2018-05-16
Vygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk
Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code AMS-9018CP) because potential friction holes may compromise product sterility.
Product
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1662-2018·2018-05-16
Siemens Syva Emit 2000 Sirolimus Assay Recalled for Interference
Siemens Healthcare Diagnostics is recalling the Syva Emit 2000 Sirolimus Assay because it may produce inaccurate results when measuring patients taking sulfasalazine or sulfapyridine.
Product
Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1650-2018·2018-05-16
Siemens Dimension ALTI Assay Recalled for Drug Interference
Siemens is recalling Dimension ALTI assays because they may produce inaccurate results when patients take sulfasalazine or sulfapyridine.
Product
Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1703-2018·2018-05-16
DePuy Recalls Two Knee Implants Due to Thread Burrs
DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.
Product
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1756-2018·2018-05-16
Cook Inc. Recalls Connecting Tubes Due to Potential Leakage or Air Aspiration
Cook Inc. is recalling 6,345 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, HPCT8.8-120-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-1785-2018·2018-05-16
TP Orthodontics Recalls Jasper Vektor Class II Correction Appliances
TP Orthodontics is recalling 126 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. 610-530 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

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23851–23875 of 40175