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

31576–31600 of 40325

HighFDA (Devices)·Z-0218-2016·2015-11-11
Brainlab Patient Data Manager Software Recalled for Image Display Errors
Brainlab AG is recalling Patient Data Manager software versions 2.0.0 through 2.1.0 because objects may display incorrectly when users deselect fused reference datasets.
Product
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0219-2016·2015-11-11
Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues
Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.
Product
HeartStart MRx monitor/defibrillator Models 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
HighFDA (Devices)·Z-0195-2016·2015-11-11
Alcon Custom Pak 9319-27 Recalled for Latex Glove Mislabeling
Alcon Research, Ltd. is recalling five units of Custom Pak 9319-27 ophthalmic surgical devices because they contain latex gloves despite being labeled as latex-free.
Product
Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0196-2016·2015-11-11
GE Recalls MR Surgical Suite II Tables Due to Transfer Mechanism Issue
GE Medical Systems is recalling MR Surgical Suite II Tables because a defect in the transfer release mechanism may prevent patient transfer between the MR and surgical tables.
Product
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0209-2016·2015-11-11
Otto Bock Triton Smart Ankle Recalled Due to Software Issue
Otto Bock is recalling the Triton Smart Ankle and iOS Galileo app due to a software issue that can cause unexpected foot movement, posing a fall risk.
Product
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2016·2015-11-11
FDA Recalls Robotic Hand Accessories Due to Pinch Hazard
Interactive Motion Technologies is recalling eight robotic hand accessories for the InMotion Arm rehabilitation robot due to a potential pinch hazard if protective covers are removed.
Product
Robotic hand accessory to InMotion Arm, rehabilitation robot.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0194-2016·2015-11-11
Baxter 15L Cycler Drainage Bags Recalled for Inlet Port Leakage
Baxter Healthcare Corp. is recalling 19,440 units of 15L Cycler Drainage Bags due to leakage from the inlet port. The products were distributed in the US and Canada.
Product
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0221-2016·2015-11-11
CareFusion Recalls SmartSite Extension Sets Due to Disconnection and Leakage
CareFusion is recalling SmartSite Extension Sets because they may disconnect or leak. The recall affects 21,000 units distributed in the US and Canada.
Product
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0226-2016·2015-11-11
GE Healthcare Recalls Centricity Universal Viewer Due to Inaccurate X-ray Measurements
GE Healthcare is recalling Centricity Universal Viewer versions 6.0 and higher because magnified projection X-ray images may display inaccurate distance measurements.
Product
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2016·2015-11-11
GE Healthcare Recalls Centricity PACS-IW Due to Inaccurate X-Ray Measurements
GE Healthcare is recalling Centricity PACS-IW software because it may display inaccurate distance measurements for magnified projection X-ray images.
Product
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0201-2016·2015-11-11
Exactech Recalls Eight Hip Implant Stems Lacking Coating
Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.
Product
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0204-2016·2015-11-11
Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation
Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.
Product
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0229-2016·2015-11-11
FDA Recalls Regard Custom Surgical Packs Due to Flow Restriction Issues
Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.
Product
Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0207-2016·2015-11-11
Arrow International Recalls PICC Kits Due to Hub Tab Detachment
Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.
Product
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or…
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-0213-2016·2015-11-11
Ivoclar Recalls Helioseal F Dental Sealant Due to Production Defect
Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.
Product
Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0228-2016·2015-11-11
Pyng Medical Recalls Tourniquets Not Reset to Ready Position
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
Product
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0216-2016·2015-11-11
ELITech Clinical Systems reagents recalled for potential drug interference
ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.
Product
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0231-2016·2015-11-11
Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.
Product
VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0203-2016·2015-11-11
Biomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error
Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.
Product
MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0214-2016·2015-11-11
ELITech Eon 100 Reagents Recalled for Potential Drug Interference
ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.
Product
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0227-2016·2015-11-11
Barco Surgical Display Recalled for Loss of User Settings After Power Cycle
Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.
Product
Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0220-2016·2015-11-11
Dako EnVision FLEX Visualization Reagent Recalled for Staining Defect
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
Product
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0222-2016·2015-11-11
Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled
Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.
Product
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0215-2016·2015-11-11
ELITech Eon 300 Reagents Recalled for Potential Drug Interference
ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.
Product
Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0217-2016·2015-11-11
ELITech Envoy 500 Reagent Kits Recalled for Potential Drug Interference
ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.
Product
Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301…
Category
Medical Device
Distribution
Distributed nationwide

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31576–31600 of 40325