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

23626–23650 of 27663

HighFDA (Devices)·Z-1273-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1280-2015·2015-03-25
Mindray Recalls Passport V Monitors Due to Inaccurate Blood Pressure Readings
Mindray is recalling 519 Passport V Monitors because the invasive blood pressure function may provide incorrect measurements.
Product
Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1272-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1274-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1271-2015·2015-03-25
Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.
Product
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1270-2015·2015-03-25
GE Healthcare Ventilators Recalled for Caster Mounting Hardware Failure Risk
GE Healthcare is recalling specific ventilator models due to a potential failure of the caster mounting hardware that could cause the device to fall or tip over.
Product
GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000. Ventilators.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1269-2015·2015-03-25
Baxter MiniCap with Povidone-Iodine Solution Recalled for Sponge Defects
Baxter Healthcare is recalling MiniCap with Povidone-Iodine Solution units for hemodialysis because the product may have separating or protruding sponges.
Product
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2015·2015-03-25
Puritan Absorbent Foam Tipped Applicator Recall Due to Shaft Breakage
Puritan Medical Products is recalling sterile absorbent foam tipped applicators because the shafts may break, preventing adequate patient specimen collection.
Product
Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1279-2015·2015-03-25
GE Healthcare Recalls Nuclear Medicine Systems Due to Collimator Detachment Risk
GE Healthcare is recalling 472 nuclear medicine systems worldwide because a collimator may fall off during rotation. No injuries have been reported.
Product
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2015·2015-03-25
Transonic Hemodialysis Monitor Recall Due to Inaccurate Flow Measurements
Transonic Systems Inc is recalling Hemodialysis Monitors that may display zero or low flow values, preventing accurate measurements during dialysis.
Product
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2015·2015-03-25
Fisher Brand Infant Heel Warmers Recalled for Burn Risk
CooperSurgical is recalling Fisher Brand Gel and Liquid Infant Heel Warmers because products without expiration dates pose a remote potential for minor burns.
Product
Fisher Brand Gel Infant Heel Gel Warmers, Cat. No.: 22-024647 Fisher Brand Liquid Infant Heel Warmer, Cat. No: 22-024646 To provide gentle heat to increase blood flow and enhance infant blood sample collection
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1292-2015·2015-03-25
Baxter HomeChoice Pro APD System Recalled for Occluder Defect
Baxter Healthcare is recalling 75 HomeChoice Pro APD systems because the occluder may have sharp edges or separate, causing system errors or therapy termination.
Product
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1286-2015·2015-03-25
Smiths Medical Recalls CADD Medication Cassette Reservoirs Due to Leak Risk
Smiths Medical is recalling specific lots of 50mL CADD Medication Cassette Reservoirs because they may leak at the sealing area. No serious injuries or deaths have been reported.
Product
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1251-2015·2015-03-18
Philips DuraDiagnost X-Ray System Recalled for Installation Defects
Philips Medical Systems is recalling 71 DuraDiagnost X-Ray systems worldwide due to improper installation risks that could cause equipment to fall or float.
Product
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1249-2015·2015-03-18
Microport Evolution Tibial Base Recalled for Casting Tool Defect
Microport Orthopedics is recalling 17 units of the Evolution Tibial Base knee prosthesis component due to a casting tool issue causing varying retaining wall thickness and keel offset.
Product
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-1247-2015·2015-03-18
Arjo Pressure IQ Evolve Mattress Recalled for Pressure Ulcer Risk
Arjo is recalling 1,034 Pressure IQ Evolve mattresses nationwide due to failures that resulted in pressure ulcers.
Product
Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1256-2015·2015-03-18
Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk
Siemens Healthcare is recalling capillary caps for RAPIDLyte blood collection devices because they may not attach properly, causing glass capillaries to break.
Product
Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311053 Legacy Part number: 478601
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1248-2015·2015-03-18
GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Cable Breakage Risk
GE Healthcare is recalling Proteus XR/a X-ray systems because a steel cable supporting the bucky device may break. A falling bucky could injure a patient or operator.
Product
GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1250-2015·2015-03-18
Pivotal Health Solutions Recalls Apollo Laser Desktop Control Units
Pivotal Health Solutions is recalling 35 Apollo Laser Desktop Control Units because internal mounting kits do not meet safety standards, increasing the risk of electric shock.
Product
Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and…
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1267-2015·2015-03-18
Siemens CT System Recalled for Image Artifacts and Safety Issues
Siemens Medical Solutions is recalling 12 SOMATOM Force CT systems due to potential image artifacts and safety-related software issues.
Product
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1258-2015·2015-03-18
Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk
Siemens Healthcare is recalling capillary caps that may fail to attach, causing glass capillaries to break.
Product
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10328655 Legacy Part number: 478527
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1260-2015·2015-03-18
Synthes Inserter for Titanium Elastic Nails Recalled for Mechanical Failure
Synthes, Inc. is recalling Inserter for Titanium Elastic Nails due to potential mechanical failures including shaft breakage and chuck malfunction.
Product
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1261-2015·2015-03-18
Dako Automated Slide Stainers Recalled for Potential Diagnostic Errors
Dako North America Inc. is recalling four models of automated slide stainers because a defect may cause buffer leakage, leading to false negative diagnostic results.
Product
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1257-2015·2015-03-18
Siemens Healthcare Recalls Capillary Caps Due to Breakage Risk
Siemens Healthcare is recalling capillary caps that may fail to attach, causing glass capillaries to break.
Product
Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection Multicap glass and Multicap-S plastic capillaries SMN: 10311054 Legacy Part number: 478605
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2015·2015-03-18
Villa Radiology Juno DFR X-ray System Recalled for Control Defects
Villa Radiology Systems LLC is recalling 30 Juno DFR X-ray systems because they lack required audible signals, permanent activation, and manual override features.
Product
Juno DFR X-ray system
Category
Medical Device
Distribution
21 states

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23626–23650 of 27663