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

25526–25550 of 27722

HighFDA (Devices)·Z-0826-2014·2014-02-05
Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach
Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.
Product
Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0871-2014·2014-02-05
Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors
Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.
Product
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0895-2014·2014-02-05
Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.
Product
Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0884-2014·2014-02-05
Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals
Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.
Product
23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2014·2014-02-05
Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure
Synergetics Inc. is recalling 72 sterile ophthalmic Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.
Product
Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0874-2014·2014-02-05
Synergetics Recalls Stiff 25ga Chow Illuminated Pick Due to Seal Failure
Synergetics Inc. is recalling 44 units of Stiff 25ga Chow Illuminated Picks because faulty seals on the outer pouch could fail, compromising sterility.
Product
Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0897-2014·2014-02-05
Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure
Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.
Product
25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0869-2014·2014-02-05
BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results
Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.
Product
BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0791-2014·2014-02-05
Philips Brilliance CT Systems Recalled for Dose Calculation Issue
Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.
Product
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0889-2014·2014-02-05
Synergetics Recalls 23ga Wide Field Corona Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.
Product
23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2014·2014-02-05
Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure
Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.
Product
25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2014·2014-02-05
BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results
Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.
Product
BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0849-2014·2014-02-05
Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise
Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.
Product
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0854-2014·2014-02-05
GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues
GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.
Product
GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0855-2014·2014-02-05
Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction
Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.
Product
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0788-2014·2014-01-29
Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 3,860 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
Product
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0789-2014·2014-01-29
Codman TRUFILL n-BCA Liquid Embolic System Recalled for Incorrect Instructions
Codman & Shurtleff, Inc. is recalling 7,983 units of the TRUFILL n-BCA Liquid Embolic System due to incorrect instructions for use.
Product
TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0812-2014·2014-01-29
Vital Signs Anesthesia Circuits Recalled Due to Occlusion Risk
Vital Signs Colorado Inc. is recalling anesthesia and ventilator circuits where a blue port cap may be attached, causing gas flow occlusion.
Product
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0780-2014·2014-01-29
Elekta XiO RTP System Recalled for Dose Calculation Error
Elekta is recalling 13 XiO RTP Systems because a software error prevents dose recalculation when proton spot beam fractions are changed.
Product
XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0813-2014·2014-01-29
Churchill Medical AMS-530 Microbore Extension Sets Recalled for Leaking
Churchill Medical Systems is recalling AMS-530 Microbore Trifurcated Extension sets because a defective component may cause the sets to leak.
Product
AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0807-2014·2014-01-29
GE Healthcare Patient Data Module Recall for ECG Noise
GE Healthcare is recalling 2,516 Patient Data Modules due to intermittent noise on ECG and respiration waveforms that may reduce monitoring performance.
Product
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0816-2014·2014-01-29
Radiometer ABL90 FLEX Analyzer Recalled for Potential Sodium Measurement Bias
Radiometer America Inc is recalling ABL90 FLEX analyzers because tilting the device may cause negative bias in sodium results.
Product
ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-0797-2014·2014-01-29
Carestream DRX-Evolution and Kodak DirectView DR 7500 Recalled for Movement Risk
Carestream Health is recalling DRX-Evolution and Kodak DirectView DR 7500 x-ray systems due to potential unexpected device movement.
Product
DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0787-2014·2014-01-29
Siemens Linac Treatment Table Recall for Finger Pinch and Cable Damage
Siemens is recalling 305 linear accelerator treatment tables due to risks of finger pinching and cable short-circuits.
Product
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR"…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0790-2014·2014-01-29
BD GeneOhm Cdiff Assay Recalled Due to Incorrect Reagent Packing
Becton Dickinson is recalling 33 kits of the BD GeneOhm Cdiff Assay because an incorrect reagent was packed, which may cause false negative results for C. difficile.
Product
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for…
Category
Medical Device
Distribution
10 states

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25526–25550 of 27722