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

3751–3775 of 5038

SevereFDA (Devices)·Z-0923-2017·2017-02-01
Philips Allura Xper FD10 X-ray System Recalled for Loose Screws
Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.
Product
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0922-2017·2017-02-01
Philips Allura Xper FD20 C-arm Recall for Loose Screws
Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.
Product
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1064-2017·2017-02-01
Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.
Product
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0925-2017·2017-02-01
Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws
Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.
Product
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1044-2017·2017-01-25
Elekta Monaco RTP System Recalled for Incorrect Dose Calculation Errors
Elekta, Inc. is recalling the Monaco RTP System because editing beam numbers and wedge angles can result in incorrect dose calculations for radiation therapy patients.
Product
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-1026-2017·2017-01-25
Fresenius 2008T Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008T Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled ultrafiltration rate instead of the displayed rate.
Product
Fresenius 2008T Series Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1027-2017·2017-01-25
Fresenius 2008K Hemodialysis System Recalled for Software Error
Fresenius Medical Care is recalling 2008K Series Hemodialysis Systems because a software error may cause the machine to execute a cancelled Ultrafiltration Rate setting.
Product
Fresenius 2008K Series : Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1029-2017·2017-01-25
Fresenius 2008K@home Hemodialysis System Recalled for Software Defect
Fresenius Medical Care is recalling 2008K@home hemodialysis systems because a software error may cause the machine to execute a cancelled ultrafiltration rate.
Product
Fresenius 2008K@home Series : Hemodialysis System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1020-2017·2017-01-18
Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound because the instrument broke during surgery.
Product
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to fi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1008-2017·2017-01-18
Smith & Nephew Recalls Reflection Dead Blow Mallets Due to Weld Cracks
Smith & Nephew is recalling Reflection Dead Blow Mallets because cracks in the weld allowed lead beads to escape into surgical wounds.
Product
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0984-2017·2017-01-18
Medline E-Z Lubricating Jelly Recalled Due to Lack of Sterilization
Medline is recalling 12,024 tubes of E-Z Lubricating Jelly because they were not sterilized due to a shipping error.
Product
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1009-2017·2017-01-18
Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations
Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.
Product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1015-2017·2017-01-18
GE Healthcare Recalls Infant Warmer Systems Due to Loose Heater Screws
GE Healthcare is recalling Infant Warmer Systems because loose screws in the Heater Head could fall and cause thermal injury to patients.
Product
Infant Warmer System (IWS)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0915-2017·2017-01-04
GE Healthcare Recalls RFX Systems Due to CRT Monitor Fall Risk
GE Healthcare is recalling RFX and other systems because aged CRT monitors may fall. This poses a risk of injury or property damage.
Product
RFX
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-0905-2017·2017-01-04
GE Healthcare Recalls ADVANTX LCA Systems Due to CRT Monitor Fall Risk
GE Healthcare is recalling ADVANTX LCA and other systems because aged CRT monitors may fall. The recall covers 1,598 units in the US and internationally.
Product
ADVANTX LCA
Category
Medical Device
Distribution
41 states
SevereFDA (Devices)·Z-0878-2017·2016-12-28
Merge OrthoCase software recall due to measurement errors
Merge Healthcare is recalling OrthoCase software because measurements change after saving, potentially causing patient injury or delayed diagnosis.
Product
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
15 states
SevereFDA (Devices)·Z-0889-2017·2016-12-28
Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise
Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.
Product
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0866-2017·2016-12-28
Northgate Technologies Recalls Laparoscopic Insufflators Due to Overpressure Risk
Northgate Technologies is recalling 49 laparoscopic insufflators because they may cause patient overpressure without visual or auditory warnings.
Product
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used fo
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0810-2017·2016-12-28
Oscor Breezeway Sheath Recalled Due to Inner Liner Fragmentation
Oscor, Inc. is recalling 255 Breezeway sheaths because a fragment of the inner liner detached during insertion, posing a risk of injury.
Product
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0782-2017·2016-12-28
FDA Recalls Ultroid Hemorrhoid Management Systems for Quality System Deficiencies
The FDA is recalling Ultroid Hemorrhoid Management Systems because they were not manufactured under required quality system controls.
Product
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Category
Medical Device
Distribution
34 states
SevereFDA (Devices)·Z-0887-2017·2016-12-28
Amendia Recalls Black Widow Spinal Screws Due to Mating Feature Defect
Amendia, Inc. is recalling 96 units of Black Widow 6.6mm spinal screws due to a design defect in the mating feature between the plate and screw.
Product
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in t
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0659-2017·2016-12-14
SynCardia Freedom Driver System Recalled for Potential Silent Failure
SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.
Product
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0647-2017·2016-12-14
Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk
Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.
Product
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0727-2017·2016-12-14
AMD-Ritmed Transparent Dressing Recalled for Sterility Failure
AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.
Product
AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-0701-2017·2016-12-14
3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect
3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.
Product
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgica
Category
Medical Device
Distribution
Distributed nationwide

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