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

21126–21150 of 40248

HighFDA (Devices)·Z-1055-2019·2019-04-03
Philips MultiDiagnost Eleva Imaging System Recalled for Missing Locking Plate
Philips is recalling MultiDiagnost Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1059-2019·2019-04-03
Fenwal CATSmart Vacuum Unit Recalled for Potential Failure During Use
Fenwal Inc is recalling 198 Vacuum Units for the CATSmart system because they may stop working and display a failure message during use.
Product
Vacuum Unit for CATSmart Vacuum Pump. Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2019·2019-04-03
Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
Smith & Nephew is recalling 65 units of the Journey II XR Tibial Posterior Keel Punch due to a higher than anticipated occurrence of bone fracture during use.
Product
JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4 , REF 74013987 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instrument used to prepare the proximal tibial to receive a JOURNEY II XR tibial baseplate.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1047-2019·2019-04-03
Avitus Bone Harvester Recalled for Potential Sterility Compromise
Avitus Orthopaedics is recalling 207 Bone Harvesters due to a breach in the sterile barrier pouch that may compromise device sterility.
Product
Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1046-2019·2019-04-03
Avitus Bone Harvester Recalled for Potential Sterility Compromise
Avitus Orthopaedics is recalling 508 Bone Harvester units because a breach in the sterile barrier pouch may compromise the device's sterility.
Product
Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1056-2019·2019-04-03
Philips URODiagnost Eleva X-ray System Recalled for Missing Locking Plate
Philips North America, LLC is recalling URODiagnost Eleva X-ray systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2019·2019-04-03
Philips MultiDiagnost-Eleva Imaging System Recalled for Missing Locking Plate
Philips is recalling MultiDiagnost-Eleva imaging systems because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.
Product
MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1041-2019·2019-04-03
Kendall SCD Express Sterile Sleeves Recalled for Sterility Failure
COVIDIEN LLC is recalling Kendall SCD Express Sterile Sleeves (Thigh Length) because they were distributed without undergoing sterilization.
Product
Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1062-2019·2019-04-03
Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver
Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.
Product
Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1064-2019·2019-04-03
Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue
Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes it difficult to engage screws and abutments.
Product
Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1061-2019·2019-04-03
Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers
Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers may be slightly oversized, making it difficult to engage screws and abutments.
Product
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1057-2019·2019-04-03
Randox Blood Gas Control Level 2 Recalled for pH Range Error
Randox Laboratories is recalling Blood Gas Control Level 2 kits due to an error in the assignment of the control range pH.
Product
Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1063-2019·2019-04-03
Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue
Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.
Product
Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-1073-2019·2019-04-03
CryoLife Recalls Two On-X Aortic Heart Valves for Mislabeled Serial Numbers
CryoLife, Inc. is recalling two On-X Aortic Heart Valves because they were mislabeled with incorrect serial numbers. The devices were distributed in Georgia and Germany.
Product
On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1031-2019·2019-03-27
CTL Medical Hex Driver Recall Due to Anti-Toggle Ring Separation Risk
CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
Product
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1030-2019·2019-03-27
CTL Medical Hex Driver Recalled Due to Anti-Toggle Ring Separation Risk
CTL Medical is recalling 133 Hex Drivers because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
Product
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1039-2019·2019-03-27
Shimadzu Mobile X-Ray System Recalled for Brake Failure
Shimadzu is recalling 93 MobileDaRt Evolution mobile X-ray systems because the brakes may fail to engage when the operator releases the drive handle.
Product
SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2019·2019-03-27
Fujifilm FDR Go PLUS Mobile X-Ray System Recalled for Braking Defect
Fujifilm is recalling 56 mobile X-ray systems because the braking mechanism may fail to engage when the handle is released.
Product
Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1036-2019·2019-03-27
ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach
ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.
Product
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2019·2019-03-27
AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts
AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.
Product
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2019·2019-03-27
ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk
ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.
Product
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2019·2019-03-27
CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise
CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.
Product
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2019·2019-03-27
FDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
The FDA is recalling 850 units of the Covidien Force TriVerse electrosurgical device due to potential sterile packaging compromise.
Product
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1015-2019·2019-03-27
Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination
Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.
Product
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1033-2019·2019-03-27
ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure
ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick because a sample failed to meet tensile strength specifications.
Product
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive…
Category
Medical Device
Distribution
Distributed nationwide

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21126–21150 of 40248