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

18401–18425 of 27647

HighFDA (Devices)·Z-1292-2018·2018-04-11
GE Healthcare Recalls Monica Novii Wireless Patch System Due to Signal Swap Risk
GE Healthcare is recalling 1,742 units of the Monica Novii Wireless Patch System because incorrectly reconnected cables may cause fetal and maternal heart rate signals to be displayed swapped.
Product
Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1278-2018·2018-04-11
Fresenius K2 Hemodialysis Machines Recalled for SLED Program Software Defect
Fresenius Medical Care is recalling 127 K2 Hemodialysis Machines because a software defect may allow the ultrafiltration pump to run at unsafe rates during SLED treatments.
Product
2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1280-2018·2018-04-11
Baxter Recalls Prismaflex Control Units Due to Software and Usage Issues
Baxter Healthcare is recalling 3,440 Prismaflex Control Units worldwide due to reports of operators failing to follow safe unloading instructions and software errors in specific versions.
Product
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2018·2018-04-11
C.R. Bard Recalls HydroSil Gripper Intermittent Catheters Due to Seal Defects
C.R. Bard is recalling specific lots of HydroSil Gripper Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.
Product
HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1300-2018·2018-04-11
DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.
Product
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1308-2018·2018-04-11
C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects
C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.
Product
Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1294-2018·2018-04-11
Seiler Alpha Air 6 ENT Microscope Recalled for Tipping Hazard
Seiler Instruments is recalling Alpha Air 6 ENT Microscopes because they may tip over if attachments are extended and the device is moved improperly.
Product
Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1293-2018·2018-04-11
GE Healthcare Recalls Monica IF24 Interface System Due to Signal Swap Risk
GE Healthcare is recalling 355 Monica IF24 Interface Systems because incorrectly reconnected cables can cause fetal and maternal heart rate signals to be displayed incorrectly.
Product
Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface Device is an accessory to the Monica AN24 which provides a means of interfacing the wireless output of the Monica AN24 to the transducer inputs of a CTG Fetal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1296-2018·2018-04-11
Magellan LeadCare Plus Blood Lead Analyzer Recalled for Battery Overheating Risk
Magellan Diagnostics is recalling 79 LeadCare Plus Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.
Product
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1295-2018·2018-04-11
Magellan LeadCare II Blood Lead Analyzer Recalled for Battery Overheating Risk
Magellan Diagnostics is recalling LeadCare II Blood Lead Analyzers because incorrect battery placement may cause overheating and potential finger burns.
Product
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1279-2018·2018-04-11
Life Technologies Recalls Oncomine Dx Target Test User Guides
Life Technologies is recalling Oncomine Dx Target Test user guides and assay definition files because they may report erroneous results when used off-label for non-NSCLC samples.
Product
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to…
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1289-2018·2018-04-11
Invivo DynaCAD Software Recalled for Incorrect Pharmacokinetic Map Display
Invivo Corporation is recalling DynaCAD software versions 3.4 and 3.5 because pharmacokinetic and ADC maps may display incorrectly on remote clients, potentially leading to underestimated values.
Product
DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1309-2018·2018-04-11
C.R. Bard Recalls Personal Intermittent Catheters Due to Seal Defects
C.R. Bard is recalling Personal Intermittent Catheters because some units were found caught in the sterile barrier seal or cut.
Product
Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52606G, 52608, 52608G, 52610, 52610G, 53314, 53320, 53514G, 53610, 53610G…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1305-2018·2018-04-11
Dynavox T15 Speech Generating Device Recalled Due to Battery Defect
Dynavox Systems LLC is recalling 307 T15 Speech Generating Devices because the integral battery may out-gas and swell after long periods of disuse, potentially causing the device case to separate.
Product
Dynavox T15 Speech Generating Device ( including Batteries)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1275-2018·2018-04-04
Ray Station Software Recalled for Potential Incorrect Radiation Treatment Volume
RaySearch Laboratories is recalling Ray Station 4.9 through 7 software due to a defect that may result in incorrect treatment volumes being delivered to patients.
Product
Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1253-2018·2018-04-04
Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues
Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
Product
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1249-2018·2018-04-04
Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues
Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.
Product
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1262-2018·2018-04-04
Allen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories
Allen Medical Systems is recalling 83 F-T3SYSTEM surgical table accessories because rail section clamps may fail during use, posing a risk of critical harm to patients.
Product
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1247-2018·2018-04-04
Stryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns
Stryker is recalling 11g Verteport Cement Cannulas because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.
Product
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1260-2018·2018-04-04
Encore Medical Recalls Altivate Anatomic Pegged Glenoid Trial Instruments
Encore Medical is recalling 93 units of Altivate Anatomic Pegged Glenoid Trials because the peg base design is larger on the trials than on the implants.
Product
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1207-2018·2018-04-04
Medtronic Recalls 6F Taiga Guiding Catheters Due to Tip Detachment
Medtronic is recalling 15,923 units of 6F Taiga Guiding Catheters distributed in Japan due to reports of tip detachment and splitting.
Product
6F Taiga Guiding Catheter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1244-2018·2018-04-04
Stryker Recalls 180-Gram Cement Cartridges Due to Sterility Assurance Issues
Stryker is recalling 708 units of 180-Gram Cement Cartridges with Breakaway Femoral Nozzles because bioburden levels were found to be higher than internal acceptable rates.
Product
180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000, UDI: (01)4546540857880 for orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1243-2018·2018-04-04
Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns
Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.
Product
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1175-2018·2018-04-04
ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues
ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.
Product
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1236-2018·2018-04-04
Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing
Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.
Product
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S…
Category
Medical Device
Distribution
Distributed nationwide

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18401–18425 of 27647