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

16151–16175 of 27471

HighFDA (Devices)·Z-1054-2019·2019-04-03
Philips OmniDiagnost X-ray System Recalled for Missing Locking Plate
Philips North America is recalling 1,696 OmniDiagnost Classic X-ray systems because a missing locking plate may cause unexpected stand or table movement that users cannot stop.
Product
Omnidiagnost Classic, Product Codes 70859, 708023, 708024, 708025 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-1071-2019·2019-04-03
ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation
ICU Medical is recalling 280 Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.
Product
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1058-2019·2019-04-03
Sunset Compressor Nebulizer Recalled for Overheating and Mouthpiece Detachment Risk
SANRAI INTERNATIONAL LLC is recalling 150 Sunset Compressor Nebulizer units in South Africa due to voltage incompatibility risks.
Product
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1066-2019·2019-04-03
Beaver Visitec Soft Tip Cannula Recall for Missing Protective Sheath
Beaver Visitec is recalling specific lots of Soft Tip Cannulas because a missing protective sheath may cause the silicone tip to break or detach during eye procedures.
Product
BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2019·2019-04-03
Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns
Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.
Product
Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1049-2019·2019-04-03
LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Risk
LW Scientific is recalling ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard.
Product
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotor to spin other fluids in test tubes (15ml)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2019·2019-04-03
Smith & Nephew Recalls Journey II XR Tibial Posterior Keel Punch
Smith & Nephew is recalling 46 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 7-8 , REF 74013988 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-1051-2019·2019-04-03
BD Synapsys Laboratory Software Recalled for Incorrect Test Order Association
Becton Dickinson is recalling BD Synapsys version 2.1 because it allowed test orders to be associated with incorrect culture records.
Product
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1069-2019·2019-04-03
Medtronic Pulmonary Vein Ablation Catheter Recalled for Phrenic Nerve Injury Risk
Medtronic is recalling PVAC GOLD catheters to reduce the potential for phrenic nerve injury during cardiac ablation procedures.
Product
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation Catheter GOLD is designed to be used for the creation of endocardial lesions (focal and linear) during cardiac ablation procedures for the treatment of symptomatic…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1065-2019·2019-04-03
Accelerate Pheno System Recalled for Incorrect Meropenem Susceptibility Results
Accelerate Diagnostics is recalling 81 Accelerate Pheno systems because rare bacterial isolates may generate incorrect meropenem susceptibility results. A software update suppresses these specific results to mitigate risk.
Product
Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1060-2019·2019-04-03
GE Healthcare Recalls Integrated ECG Cables Due to Short Circuit Risk
GE Healthcare is recalling 288 integrated ECG cables that can short circuit during defibrillation, potentially diverting 25% of the energy away from the patient.
Product
Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1067-2019·2019-04-03
Philips MX40 Wearable Monitor Batteries Recalled for Manufacturing Defect
Philips North America is recalling 40 lithium-ion rechargeable batteries for the MX40 Wearable Monitor due to a manufacturing defect that may affect monitor operation.
Product
Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF: 989803176201 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2019·2019-04-03
LW Scientific ZIP IQ PCV Centrifuge Recalled for Rotor Breakage Risk
LW Scientific is recalling 142 ZIP IQ PCV Centrifuges because the plastic rotor may break and be ejected, posing a safety hazard to technicians.
Product
LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2019·2019-04-03
LW Scientific ZIP IQ Combo Centrifuge Rotor Recall for Breakage Hazard
LW Scientific is recalling 16 ZIP IQ Combo Centrifuges because the hematocrit rotor may break and eject through the housing, posing a safety hazard to technicians.
Product
LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-4RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hematocrit tubes with additional rotors to spin other fluids in test tubes (15ml and 50ml), microtubes, and PCR strips
Category
Medical Device
Distribution
Distributed nationwide
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
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

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16151–16175 of 27471