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

36176–36200 of 40325

ModerateFDA (Devices)·Z-1154-2014·2014-03-19
Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error
Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.
Product
RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1156-2014·2014-03-19
Mindray Recalls Panorama Central Station for Time Clock Data Lag
Mindray is recalling 732 Panorama Central Stations because Full Disclosure data and event indicators may lag behind the system time clock.
Product
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1196-2014·2014-03-19
Gyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits
Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.
Product
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1190-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.
Product
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing…
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1203-2014·2014-03-19
DePuy S-ROM Rotating Hinge Recall Due to Sterile Barrier Defect
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.
Product
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1153-2014·2014-03-19
Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch
Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.
Product
Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1180-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices…
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1152-2014·2014-03-19
Leica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing
Leica Biosystems is recalling 78 units of the ScanScope System software to clarify usage with specific RUO products.
Product
HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use…
Category
Medical Device
Distribution
12 states
ModerateFDA (Devices)·Z-1191-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
Product
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices…
Category
Medical Device
Distribution
40 states
LowFDA (Devices)·Z-1193-2014·2014-03-19
Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.
Product
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1166-2014·2014-03-19
Steris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error
Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.
Product
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1143-2014·2014-03-12
Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect
Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.
Product
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1060-2014·2014-03-12
McKesson Anesthesia Care System Recalled for Data Mismatch
McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.
Product
McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1150-2014·2014-03-12
Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk
Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.
Product
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1119-2014·2014-03-12
Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns
Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.
Product
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1082-2014·2014-03-12
Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors
Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.
Product
Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2014·2014-03-12
Elekta RT Desktop Software Recall for Calibration Input Errors
Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.
Product
RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a…
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1084-2014·2014-03-12
Elekta Agility Software Recall for Calibration Input Errors
Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.
Product
Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2014·2014-03-12
Elekta Agility software recall for potential calibration input errors
Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.
Product
Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1134-2014·2014-03-12
DeRoyal Circumcision Clamps Recalled for Manufacturing Defects
DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.
Product
DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1083-2014·2014-03-12
Elekta Integrity Software Recalled for Calibration Input Errors
Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.
Product
Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2014·2014-03-12
GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure
GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.
Product
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2014·2014-03-12
Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure
Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.
Product
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2014·2014-03-12
Medical Information Technology Recalls MEDITECH Microbiology Calculator Module
Medical Information Technology, Inc. is recalling MEDITECH Microbiology calculator modules due to a risk of patient results being removed from laboratory and electronic medical record systems.
Product
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1127-2014·2014-03-12
Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage
Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.
Product
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray…
Category
Medical Device
Distribution
Distributed nationwide

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36176–36200 of 40325