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

24876–24900 of 27722

HighFDA (Devices)·Z-2131-2014·2014-08-06
Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure
Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.
Product
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2118-2014·2014-08-06
Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment
Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.
Product
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2123-2014·2014-08-06
Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect
Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.
Product
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2014·2014-08-06
Teleflex Recalls RUSCH TruLite Disposable Laryngoscope Handles
Teleflex Medical is recalling RUSCH TruLite laryngoscope handles because the handle may heat up and melt the end cap.
Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2014·2014-08-06
Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss
Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.
Product
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2068-2014·2014-07-30
GE Healthcare Recalls DateX-Ohmeda S/5 Airway Modules Due to CO2 Measurement Failure
GE Healthcare is recalling DateX-Ohmeda S/5 Single-Width Airway Modules and E-miniC accessories because a CO2 detector failure may cause incorrect low readings, potentially impairing clinical decision-making for ventilated patients.
Product
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2080-2014·2014-07-30
Stryker Recalls Disposable StrykeFlow Tips Due to Sterility Concerns
Stryker Endoscopy is recalling 496 boxes of Disposable StrykeFlow Tips because a deformed blister pouch could compromise the product's sterility.
Product
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1468-2014·2014-07-30
Trinity Care Solutions Recalls Normal Saline Syringes Due to Sterility Concerns
Trinity Care Solutions is recalling Normal Saline 10 mL syringes in Florida due to quality control concerns identified during an FDA inspection.
Product
Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2021-2014·2014-07-30
Blood Glucose Test Strips Recalled for Inappropriate Labeling and Marketing
Diabetic Supply of Suncoast, Inc. is recalling Advocate Redi-Code+ blood glucose test strips because they were inappropriately labeled and marketed.
Product
ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2014·2014-07-30
Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk
Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.
Product
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2014·2014-07-30
Heartsine AED Electrode Pouches Recalled for Difficulty Opening
Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.
Product
Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2100-2014·2014-07-30
Terumo Recalls Sarns Two-stage Venous Return Cannulae Due to Particulate
Terumo CVS is recalling Sarns Two-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2014·2014-07-30
Philips QLAB 10 Core Module Software Recall for Measurement Defect
Philips Ultrasound is recalling QLAB 10 Core Module software due to a defect that may use incorrect measurement values under specific conditions.
Product
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-2114-2014·2014-07-30
GE Healthcare Recalls CARESCAPE Monitor B650 Due to Sound Loss
GE Healthcare is recalling CARESCAPE Monitor B650 units because they may lose alarm sounds when an external display is connected via a USB extender with an active hub.
Product
GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2014·2014-07-30
Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect
Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.
Product
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2089-2014·2014-07-30
Perouse Flamingo Inflation Devices Recalled for Potential Water-Tightness Defect
Perouse Medical is voluntarily recalling specific batches of Flamingo Inflation Devices due to a potential water-tightness defect that could allow air entry during cardiovascular procedures.
Product
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2082-2014·2014-07-30
DePuy RECLAIM Taper Protector Sleeve Recalled for Removal Difficulty
DePuy Orthopaedics is recalling 814 RECLAIM Taper Protector Sleeves because the product can be difficult to remove from the Distal Stem.
Product
RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
Category
Medical Device
Distribution
49 states
HighFDA (Devices)·Z-2085-2014·2014-07-30
GE Healthcare CARESCAPE Patient Monitors Recalled for Data Loss
GE Healthcare is recalling CARESCAPE B850, B650, and B450 patient monitors because the Patient Data Module may fail to communicate, causing partial loss of monitoring parameters.
Product
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2111-2014·2014-07-30
Siemens syngo Imaging XS Software Recall for Potential Miscalculation
Siemens is recalling syngo Imaging XS software due to potential miscalculation of grey scale values in specific image processing functions.
Product
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2014·2014-07-30
Invacare Recalls M41 Wheelchair Controllers Due to Programming Error
Invacare is recalling 819 M41 powered wheelchair controllers that may cause momentary loss of control due to non-standard factory programming.
Product
MK5 NX Controller--Wheelchair controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2096-2014·2014-07-30
Terumo Recalls Sarns Venous Return Cannulae Due to Loose Fiber Particulate
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2014·2014-07-30
Alphatec Spine Recalls Solanas 2.1mm Fixed Depth Drill
Alphatec Spine is recalling 14 units of the Solanas 2.1mm Fixed Depth Drill because the golden stop slid from its fixed position during use.
Product
Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2014·2014-07-30
Terumo Recalls Sarns Soft-Flow Aortic Cannulae Due to Fiber Particulate
Terumo CVS is recalling Sarns Soft-Flow Aortic Cannulae because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2014·2014-07-30
Terumo Recalls Sarns Soft-arc Aortic Cannula Due to Loose Fiber Particulate
Terumo CVS is recalling 20 units of Sarns Soft-arc Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.
Product
Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2014·2014-07-30
Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Electrolyte Error Codes
Siemens Healthcare Diagnostics Inc is recalling RAPIDPoint 500 Lactate Cartridges because they may display error codes for electrolyte parameters.
Product
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part…
Category
Medical Device
Distribution
Distributed nationwide

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24876–24900 of 27722