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

15501–15525 of 27500

HighFDA (Devices)·Z-2113-2019·2019-08-07
Burlington Medical Recalls Radiation Protection Vests Due to Inadequate Shielding
Burlington Medical is recalling 22 radiation protection vests because the protective material may provide inadequate shielding against scatter radiation.
Product
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM Product Usage: Products are designed to protect healthcare workers against scatter…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2019·2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 23 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing health risks for users.
Product
Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2086-2019·2019-08-07
Teleflex Recalls Rusch EasyCath Kits Due to Sterility Concerns
Teleflex Medical is recalling 3,700 Rusch EasyCath Kits because they may not be sterile. The kits were distributed nationwide to eight states.
Product
Rusch EasyCath Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2112-2019·2019-08-07
Burlington Medical Recalls 310 Full Wrap Vests and Kilts for Radiation Protection Defects
Burlington Medical is recalling 310 two-piece full wrap vests and kilts because the protective material may provide inadequate shielding against scatter radiation.
Product
2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REVK*F, REVK*M, REVKB, REVKC, REVKE, REVKXXLM, SEVK*F, SEVK*M, SEVKB, SEVKC, SEVKE, SEVKF, SEVKG, SEVKXLF, SEVKXXLM, UEVK*F, UEVK*M, UEVKXXLF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2019·2019-08-07
Inovo Single Luman Conserver Recalled for Potential Pressure Gauge Dislodgement
Inovo, Inc. is recalling 690 Single Luman Conservers because the pressure gauge may dislodge from the mount, creating a leak.
Product
Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2119-2019·2019-08-07
Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection
Burlington Medical is recalling 210 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to increased health risks.
Product
Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2118-2019·2019-08-07
Burlington Medical Recalls Radiation Protection Kilts Due to Inadequate Shielding
Burlington Medical is recalling 37 radiation protection kilts because the protective material may provide inadequate shielding against scatter radiation.
Product
Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2058-2019·2019-07-31
Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect
Zyno Medical LLC is recalling administration sets with inverted pinch clamps that may cause blood to be drawn from patients instead of delivering fluid.
Product
Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2081-2019·2019-07-31
GammaPod Stereotactic Radiotherapy System Recalled for Alignment Drift
Xcision Medical Systems is recalling two GammaPod Stereotactic Radiotherapy Systems because a loose bolt caused alignment drift and reduced radiation dose output.
Product
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-2084-2019·2019-07-31
Randox RX Imola Recalled Due to Sensor Malfunction and Internal Damage
Randox Laboratories is recalling 27 RX Imola instruments after a sensor malfunction caused internal wire melting and scorch damage.
Product
RX Imola, Model Nos. RX4900
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2010-2019·2019-07-31
Philips BrightView X Handcontroller Recall for Uncommanded Motion Risk
Philips Medical Systems is recalling 117 BrightView X devices because a handcontroller issue may cause spontaneous or continued motion.
Product
BrightView X , Model Number 882478
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2019·2019-07-31
Philips BrightView XCT Medical Device Recalled for Handcontroller Motion Defect
Philips Medical Systems is recalling 427 BrightView XCT devices because a handcontroller issue may cause uncommanded motions or continued motion after buttons are released.
Product
BrightView XCT , Model Number 882482
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2060-2019·2019-07-31
GE Healthcare Recalls MAC VU360 Electrocardiographs Due to Patient ID Errors
GE Healthcare is recalling 369 MAC VU360 electrocardiographs because they may display incorrect patient IDs or demographics, potentially assigning ECG reports to the wrong patient.
Product
MAC VU360, Model Number 2030360-001, Electrocardiograph
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2026-2019·2019-07-31
Siemens AXIOM Artis TC X-ray Generator Recall for Power Supply Issue
Siemens is recalling one AXIOM Artis TC unit due to a power supply tolerance issue that may cause X-ray generation failure during procedures.
Product
AXIOM Artis TC, Model Number 7728350
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2080-2019·2019-07-31
Bard Nautilus Delta Port Kits Recalled for ECG Signal Loss
Bard Peripheral Vascular is recalling specific Nautilus Delta Port Kits due to a risk of losing the intravascular ECG signal during placement procedures.
Product
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2019·2019-07-31
Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Barrier Defect
Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Product
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2019·2019-07-31
InfuTronix Nimbus Administration Set Recalled for Potential Tube Leakage
InfuTronix LLC is recalling Nimbus Administration Sets due to a potential for tube leakage. The recall affects 10,800 units distributed in Massachusetts.
Product
Nimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2025-2019·2019-07-31
Siemens AXIOM Artis dFC X-ray Generator Recall for Power Supply Issue
Siemens is recalling 19 AXIOM Artis dFC units because a power supply tolerance issue may cause generator failure, preventing X-ray procedures.
Product
AXIOM Artis dFC, Model Number 7727717
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2019·2019-07-31
Zyno Medical Administration Sets Recalled Due to Inverted Pinch Clamp Defect
Zyno Medical LLC is recalling administration sets where an inverted pinch clamp may cause blood to be drawn from the patient instead of delivering fluid.
Product
Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code: B2-70072-F
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2035-2019·2019-07-31
Spacelabs Smart Disclosure System Recalled for Patient Data Mismatch
Spacelabs Healthcare is recalling the Smart Disclosure System because patient records were printed with waveforms from other patients.
Product
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2002-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 844,000 Sur-vet Needles because a loss of package integrity may compromise the sterility of the product.
Product
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-2042-2019·2019-07-31
Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns
Cardinal Health is recalling specific lots of Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Product
Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 8881200664
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2053-2019·2019-07-31
MOOG Curlin Infusion Administration Set Recalled for Filter Leaks
Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.
Product
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2041-2019·2019-07-31
Cardinal Health Recalls Monoject Hypodermic Needles Due to Sterility Concerns
Cardinal Health is recalling Monoject Standard Hypodermic Needles because a manufacturing defect in the cartridge component could compromise the product's sterility barrier.
Product
Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2003-2019·2019-07-31
Terumo Sur-vet Needle Recall Due to Potential Loss of Package Integrity
Terumo Medical Corporation is recalling 563,000 Sur-vet Needles because a potential loss of package integrity may compromise the sterility of the product.
Product
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Category
Medical Device
Distribution
12 states

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15501–15525 of 27500