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

35201–35225 of 40325

ModerateFDA (Devices)·Z-2180-2014·2014-08-20
Siemens Syngo RT Software Recalled for Sporadic System Crashes
Siemens is recalling Syngo RT Therapist and Oncologist software versions 4.3.SP1 due to sporadic system crashes that prevent unloading patient data.
Product
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2185-2014·2014-08-20
Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.
Product
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Medical Device
Distribution
43 states
ModerateFDA (Devices)·Z-2188-2014·2014-08-20
Codman Certas Valve Recalled for Pressure Specification Clarification
Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.
Product
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Category
Medical Device
Distribution
43 states
LowFDA (Devices)·Z-2233-2014·2014-08-20
BD Multi Check CD4 Low Control Recalled for Incorrect Date Labeling
BD Biosciences is recalling 85 units of BD Multi Check CD4 Low Control due to an incorrect distribution date on the outer box label.
Product
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Category
Medical Device
Distribution
9 states
LowFDA (Devices)·Z-2178-2014·2014-08-20
Agfa Healthcare Recalls Radiographic Film Due to Fogged Sheets
Agfa Healthcare is recalling specific lots of radiographic film because some sheets are fogged, which may affect image quality.
Product
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF Product Usage: Radiographic film is a device that…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2120-2014·2014-08-20
Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.
Product
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2176-2014·2014-08-20
Agfa Digital Radiography X-Ray System Recalled for Mislabeled Output Power
AGFA Healthcare Corp. is recalling one Agfa Digital Radiography X-Ray System DX-D 100 unit in West Virginia because it was mislabeled with a factory label showing 32 KW output power.
Product
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2159-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2164-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2162-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2137-2014·2014-08-13
Carestream KODAK DirectView DR 9000 X-Ray System Recalled for Control Failure
Carestream Health is recalling KODAK DirectView DR 9000 systems because a control failure may cause the U-Arm to move downward unexpectedly at three times the normal speed.
Product
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2156-2014·2014-08-13
Stryker Recalls Sonopet Ultrasonic Surgical Systems Due to Irrigation Defect
Stryker is recalling 2,460 Sonopet Ultrasonic Surgical Systems because insufficient irrigation to the tip can potentially lead to excessive heat.
Product
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2140-2014·2014-08-13
Ortho VITROS 4600 Chemistry System Recalled for Software Error
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may associate incorrect patient demographics with sample IDs.
Product
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2163-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak
ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.
Product
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2151-2014·2014-08-13
Coltene Whaledent Recalls Latex Dental Dams Labeled as Non-Latex
Coltene Whaledent Inc. is recalling latex dental dams that were incorrectly packaged in non-latex packaging, posing a risk to patients with latex allergies.
Product
Latex Dental Dams labeled as Non-Latex Dental Dams
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2165-2014·2014-08-13
ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk
ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause a fluid leak.
Product
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2158-2014·2014-08-13
ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 units of Trifurcated Transpac IT Monitoring Kits because a component connection may crack and cause a fluid leak.
Product
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2153-2014·2014-08-13
PerkinElmer Recalls Panthera-Puncher 9 Sample Transfer Instruments
PerkinElmer is recalling 144 Panthera-Puncher 9 sample transfer instruments because they may produce incorrect results from dried blood samples.
Product
Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2157-2014·2014-08-13
ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.
Product
Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2160-2014·2014-08-13
ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.
Product
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2166-2014·2014-08-13
PerkinElmer Specimen Gate Software Recalled for Data Mismatch Risk
PerkinElmer is recalling Specimen Gate Screening Center software versions 1.4 and 1.6 due to a potential mismatch between demographic information and test results.
Product
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2146-2014·2014-08-13
Brainlab ExacTrac Software Recall for Potential Radiation Misalignment
Brainlab AG is recalling ExacTrac v6.0.4 software because it may move patients to the wrong position during radiation treatment, potentially delivering the dose to an unintended target.
Product
ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2161-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2138-2014·2014-08-13
Advandx Quick FISH Fixation Kit Recalled for Quality Control Failure
Advandx Inc is recalling 10 kits of the Quick FISH Fixation Kit for Blood Cultures because they failed internal quality control tests.
Product
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50)
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-2139-2014·2014-08-13
Ortho VITROS 3600 Immunodiagnostic System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 3600 systems due to a software defect that may associate incorrect patient demographics with sample IDs.
Product
VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, &…
Category
Medical Device
Distribution
Distributed nationwide

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