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

29176–29200 of 40449

ModerateFDA (Devices)·Z-2743-2016·2016-09-14
Integra Recalls Achillon Suture System Due to Sterility Concerns
Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.
Product
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2748-2016·2016-09-14
Mentor CPX4 Breast Tissue Expanders Recalled for Product Mix-Up
Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.
Product
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2744-2016·2016-09-14
Ecolab Recalls Microtek Angiography Drapes Due to Packaging Defects
Ecolab is recalling specific Microtek angiography drapes because their sterile packaging may contain small holes in the film, potentially compromising sterility.
Product
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2752-2016·2016-09-14
Zimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts
Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.
Product
Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the…
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2767-2016·2016-09-14
Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect
Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.
Product
Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2755-2016·2016-09-14
Aspen Surgical Recalls Misidentified Stainless Steel Surgical Blades
Aspen Surgical Puerto Rico Corp. is recalling 6,000 stainless steel surgical blades that were incorrectly labeled as size 12 instead of 12B.
Product
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2754-2016·2016-09-14
Anthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure
Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed the firm failed to validate the design and process of the devices.
Product
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2753-2016·2016-09-14
Anthogyr Axiom REG Dental Implants Recalled for Design Validation Failure
Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.
Product
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2759-2016·2016-09-14
Teleflex Horizon Manual-Load Ligating Clip Applier Recalled for Incorrect Etching
Teleflex Medical is recalling 49 units of Horizon Manual-Load Ligating Clip Appliers due to incorrect etching on the device.
Product
WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2720-2016·2016-09-14
ReliaMed Alginate Dressings Recalled for Misplaced Instructions
Advanced Medical Solutions is recalling ReliaMed Alginate/CMC dressings because instructions for use were misplaced in the packaging.
Product
ReliaMed¿ Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2757-2016·2016-09-14
Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect
Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.
Product
Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2739-2016·2016-09-14
GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.
Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2741-2016·2016-09-14
Arrow Radial Artery Catheterization Kits Recalled for Shipping Labeling Error
Arrow International Inc. is recalling 690 Radial Artery Catheterization Kits due to a shipping carton labeling error. The kits were distributed to Ohio, Indiana, Tennessee, North Carolina, and Kentucky.
Product
Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2719-2016·2016-09-14
ReliaMed Silver Alginate Dressing Recalled for Missing Instructions
Advanced Medical Solutions is recalling ReliaMed Silver Alginate dressings because some cartons are missing the required Instructions For Use leaflet.
Product
ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-2740-2016·2016-09-14
Arrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error
Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits due to a shipping carton labeling error. The kits were distributed nationwide to five states.
Product
Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2675-2016·2016-09-07
Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.
Product
STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2676-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.
Product
STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2677-2016·2016-09-07
Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.
Product
CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2681-2016·2016-09-07
Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard
Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.
Product
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-2692-2016·2016-09-07
Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Due to Fire Risk
Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer because flammable liquids may contact electrical components, posing a fire hazard.
Product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2673-2016·2016-09-07
Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling
Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.
Product
Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2713-2016·2016-09-07
Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp
Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.
Product
The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2683-2016·2016-09-07
Teleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking
Teleflex Medical is recalling 2,700 MAQUET Servo Humidifier 163 units because the ISO female connector may crack. The units were distributed to Florida, Kansas, and West Virginia.
Product
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2709-2016·2016-09-07
Merge Cardio software recall due to incorrect patient data saving
Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.
Product
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2691-2016·2016-09-07
Elekta Recalls HexaPOD evo RT Systems for Positioning Errors
Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.
Product
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
Category
Medical Device
Distribution
Distributed nationwide

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29176–29200 of 40449