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 deaths or serious injuries are reported, 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

4276–4300 of 5111

CriticalFDA (Devices)·Z-1035-2015·2015-02-25
GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay
GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.
Product
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2015·2015-02-25
CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk
CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.
Product
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2015·2015-02-25
Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.
Product
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1051-2015·2015-02-18
Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.
Product
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tu
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1092-2015·2015-02-18
Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks
Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.
Product
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1008-2015·2015-02-18
Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks
Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.
Product
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the t
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1090-2015·2015-02-18
Stryker Recalls MEDPOR Surgical Implants Due to Potential Intraoperative Damage
Stryker is recalling MEDPOR Surgical Implants because they may crack or break during surgery. The recall affects 1,051 units distributed worldwide.
Product
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and r
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1091-2015·2015-02-18
Stryker Recalls MEDPOR BARRIER Sheets for Potential Deformation and Cracking
Stryker is recalling MEDPOR BARRIER Sheets due to risks of deformation, cracking, and loss of adhesion during surgery.
Product
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and M
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1089-2015·2015-02-18
Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect
Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.
Product
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1059-2015·2015-02-11
Siemens LINAC Accelerators Recalled for Overheating and Smoke Emission
Siemens Medical Solutions is recalling 310 LINAC Accelerators because the internal electric board may overheat, causing thermal damage and smoke emission.
Product
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1034-2015·2015-02-11
Animas Vibe Insulin Pump Recalled Due to Calibration Factor Overwrite
Animas Corporation is recalling 1,235 Vibe Insulin Infusion Pumps because calibration factors were overwritten, potentially causing the pump to fail to detect cartridges or alarms.
Product
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1054-2015·2015-02-11
Cardinal Health Recalls Lubricated Intubating Stylets Due to Shear Risk
Cardinal Health is recalling 104,432 Lubricated Intubating Stylets 6FR because a small piece of the sheath may shear off during removal, posing a risk to infants and pediatric patients.
Product
Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1013-2015·2015-02-04
Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk
Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.
Product
Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0996-2015·2015-01-28
TransMotion Medical Recalls Powered Stretcher Chairs Due to Involuntary Movement
TransMotion Medical Inc is recalling 1,127 powered stretcher chairs used in surgeries because the controllers may cause the chairs to move involuntarily.
Product
Powered stretcher chair used during facial and eye surgeries. One chair per package.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0980-2015·2015-01-21
Siemens Linear Accelerators Recalled for Unauthorized Component Safety Risks
Siemens Medical Solutions is recalling 320 linear accelerators because unauthorized third-party components may cause patient or operator injury and dose calculation errors.
Product
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0963-2015·2015-01-21
Philips HeartStart MRx Monitor/Defibrillator Recalled for Malfunction Risk
Philips is recalling HeartStart MRx monitor/defibrillators because the device may malfunction, potentially delaying or disabling therapy or delivering it inadvertently.
Product
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0915-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 23mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 23mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific a
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0917-2015·2015-01-21
Boston Scientific Recalls Lotus TAVR 27mm Transcatheter Aortic Valve Prosthesis
Boston Scientific is recalling 278 units of the Lotus TAVR 27mm valve because the device may unlock during release, potentially causing the valve to embolize.
Product
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific ao
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0953-2015·2015-01-21
DePuy ATTUNE INTUITION Impaction Handle Recalled for Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impaction Handles because the lever can fracture during knee surgery, potentially leaving device pieces in the patient.
Product
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impact
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0951-2015·2015-01-21
FDA Recalls Unapproved Color Contact Lenses Contaminated with Bacteria
Intertrade Imports Inc. is recalling I Color Complete contact lenses because FDA testing found bacteria and the product is not sterile.
Product
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Targe
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0931-2015·2015-01-14
Synthes Small Electric Drive Recalled for Unintended Start and Malfunction
Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.
Product
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and h
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0905-2015·2015-01-14
DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.
Product
Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its rele
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0908-2015·2015-01-14
DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk
DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.
Product
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to as
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0924-2015·2015-01-14
Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement
Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables because complaints were reported of unintended movement during surgical cases.
Product
(R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sys
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-0923-2015·2015-01-14
Trumpf Medical Systems Recalls IIR Remote Controls for Operating Tables
Trumpf Medical Systems is recalling IIR remote controls for JUPITER operating tables due to reports of unintended movement during surgery.
Product
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer syste
Category
Medical Device
Distribution
25 states

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4276–4300 of 5111