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

25426–25450 of 27686

HighFDA (Devices)·Z-0929-2014·2014-02-12
Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.
Product
ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0936-2014·2014-02-12
Ossur Recalls Symbionic Leg Prostheses Due to Electronics Defect
Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.
Product
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0914-2014·2014-02-12
GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob
GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.
Product
Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2014·2014-02-12
GE Healthcare Panda Infant Warmers Recalled for Loose Adjustment Knob
GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Product
Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2014·2014-02-12
B. Braun AccuFlo Elastomeric Infusion Pump Recalled for Flow Rate Issues
B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.
Product
B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0928-2014·2014-02-12
Elekta XiO RTP System Recalled for Incorrect Effective Depth Calculation
Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.
Product
XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0911-2014·2014-02-12
GE Healthcare Recalls X-ray Systems Due to Monitor Suspension Nut Issue
GE Healthcare is recalling Precision 500D, MPI, and RXI X-ray systems because a locking nut on the overhead monitor suspension may loosen.
Product
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0912-2014·2014-02-12
GE Healthcare Recalls Giraffe Infant Warmers Due to Loose Adjustment Knob
GE Healthcare is recalling 1,970 Giraffe Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Product
Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0916-2014·2014-02-12
GE Healthcare Recalls Stand-Alone Resuscitation T-Pieces Due to Loose Knob
GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.
Product
Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2014·2014-02-12
Siemens SOMATOM CT Systems Recalled for Potential Display Freeze Malfunction
Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.
Product
Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0838-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0834-2014·2014-02-05
DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure
DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0859-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
Product
Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0836-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0839-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0837-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks
DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0862-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.
Product
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0860-2014·2014-02-05
Codman Certas Programmable Valves Recalled for Potential Malfunction
Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.
Product
Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0835-2014·2014-02-05
DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure
DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.
Product
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0885-2014·2014-02-05
Synergetics Recalls 25ga Endo Illuminator Due to Faulty Seals
Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices because faulty seals on the outer pouch could fail, potentially compromising sterility.
Product
25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0899-2014·2014-02-05
Synergetics Recalls 25ga Aspirating Endo Illuminator Due to Seal Failure
Synergetics is recalling 25ga Aspirating Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.
Product
25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0877-2014·2014-02-05
Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals
Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.
Product
25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0886-2014·2014-02-05
Synergetics Recalls Stiff 25ga Endo Illuminator Due to Faulty Seals
Synergetics Inc is recalling 48 units of Stiff 25ga Endo Illuminators because faulty seals on the outer pouch could result in seal failure.
Product
Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2014·2014-02-05
Synergetics Recalls Corona Shielded Wide Field Endo Illuminator Due to Seal Failure
Synergetics Inc. is recalling specific lots of Corona Shielded Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.
Product
"The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2014·2014-02-05
Synergetics Recalls 29ga Ophthalmic Chandeliers Due to Faulty Seals
Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the devices.
Product
29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Category
Medical Device
Distribution
Distributed nationwide

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