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

38176–38200 of 40449

ModerateFDA (Devices)·Z-1611-2013·2013-07-03
Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error
Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.
Product
Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1563-2013·2013-07-03
Thermo Scientific MAS Bilirubin Recalled for Reduced Stability
Microgenics Corporation is recalling Thermo Scientific MAS Bilirubin test samples because in-house testing confirmed reduced stability of Direct and Total Bilirubin.
Product
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1612-2013·2013-07-03
Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling
Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.
Product
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1519-2013·2013-07-03
GE Healthcare Recalls Senographe Essential Mammography Systems Due to Manual Defect
GE Healthcare is recalling 49 Senographe Essential mammography systems because a defective CD makes the operator manual inaccessible.
Product
GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1568-2013·2013-07-03
Integra LifeSciences Recalls Ascension CMC Saddle Due to Labeling Discrepancies
Integra LifeSciences is recalling 467 Ascension CMC Saddle implants because the US Instruction for Use contains content discrepancies compared to the FDA-cleared version.
Product
CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1596-2013·2013-07-03
STERIS Recalls Quick Connects for Labeling Updates
STERIS Corporation is recalling four Quick Connect products to update labeling and remove obsolete device models.
Product
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1615-2013·2013-07-03
Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because an excess amount of surfactant was unintentionally added during manufacturing.
Product
VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1614-2013·2013-07-03
Ortho-Clinical VITROS Potassium Slides Recalled for Unintentional Surfactant Addition
Ortho-Clinical Diagnostics is recalling VITROS Potassium Slides because a surfactant was unintentionally added during manufacturing.
Product
VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1558-2013·2013-06-26
Verathon Recalls GlideScope Reusable Laryngoscope Blades Due to Breakage Risk
Verathon is recalling GlideScope reusable laryngoscope blades because the tips may break prematurely without visible signs, posing a risk to patients during intubation.
Product
GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1537-2013·2013-06-26
Respironics V60 Ventilator Recalled for Power Management Board Software Issue
Respironics is recalling V60 ventilators due to a software issue on the Power Management Board Assembly that could cause loss of ventilator support without an audible alarm.
Product
Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a)…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1548-2013·2013-06-26
Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset
Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.
Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1547-2013·2013-06-26
Biomet Recalls Phoenix Retrograde Femoral Connecting Bolts Due to Fit Issues
Biomet is recalling 75 Phoenix Retrograde Femoral Connecting Bolts because an undersized diameter may cause the hex driver to get stuck, delaying surgery.
Product
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1551-2013·2013-06-26
GE Healthcare Recalls PET VCAR Software Due to Calculation Error
GE Healthcare is recalling PET VCAR software due to a potential safety issue with automated PERCIST response criteria calculations.
Product
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1561-2013·2013-06-26
Linde Gas Recalls MEDICYL-e Portable Oxygen Systems Due to Valve Defect
Linde Gas North America is recalling MEDICYL-e Portable Oxygen Systems because some units may have misapplied valve flow knobs.
Product
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2013·2013-06-26
Philips BuckyDiagnost Radiographic Systems Recalled for Table Height Defects
Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.
Product
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2013·2013-06-26
Zimmer Patient Helper Bed Frame Adapter Assembly Recalled for Weak Welds
Zimmer, Inc. is recalling 344 Patient Helper Bed Frame Adapter Assemblies because they may have a weak weld where the mounting bars attach to the tube.
Product
Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1560-2013·2013-06-26
Tecan Freedom EVO Software Recall for Door Lock Safety Defect
Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.
Product
Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1555-2013·2013-06-26
Prism Medical Recalls BC Hammock Mesh Sling for Incorrect Size
Prism Medical Services USA is recalling BC Hammock Mesh Sling (Junior) units because they were produced in the incorrect size.
Product
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1553-2013·2013-06-26
Prism Medical Recalls BC Hammock Mesh Slings Due to Incorrect Size
Prism Medical Services USA is recalling 5 BC Hammock Mesh Slings (Large) because they were produced in the incorrect size.
Product
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1545-2013·2013-06-26
SybronEndo Recalls Dental Power Cords Due to Missing Safety Label
SybronEndo is recalling 3,615 Elements Obturation Unit power cords because a required Canadian safety label was accidentally omitted from the packaging.
Product
SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1556-2013·2013-06-26
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products-HCY Reagent Lot 1529-17-2636
Ortho-Clinical Diagnostics is recalling a specific lot of VITROS Chemistry Products-HCY Reagent because it produced lower than expected results.
Product
VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1549-2013·2013-06-26
Aperio ScanScope Systems Recalled for Incorrect User Guide Labeling
Aperio Technologies is recalling 364 ScanScope systems because user guides incorrectly claim FDA clearance for diagnostic use, when the devices are for research only.
Product
Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1559-2013·2013-06-26
Hitachi Recalls Echelon and Oasis MR Imaging Systems Due to Software Error
Hitachi is recalling 45 Echelon, Echelon Oval, and Oasis MR imaging systems due to a software error that can cause image data loss during simultaneous scanning and processing.
Product
Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box. The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1562-2013·2013-06-26
Siemens ARTISTE Linear Accelerator Recall for Image Quality Degradation
Siemens is recalling 8 ARTISTE linear accelerators due to potential image quality degradation that may affect patient position verification during cancer treatment.
Product
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1544-2013·2013-06-26
SybronEndo Elements Obturation Unit Recalled for Missing Safety Label
SybronEndo is recalling 3,615 Elements Obturation Units because a required Canadian safety caution label was accidentally omitted from the device and its power cord.
Product
SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C…
Category
Medical Device
Distribution
Distributed nationwide

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38176–38200 of 40449