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

25301–25325 of 27722

HighFDA (Devices)·Z-1225-2014·2014-03-26
Philips HeartStart FR3 AED Recalled for Potential Circuit Board Separation
Philips is recalling HeartStart FR3 AEDs because the circuit board may separate, preventing the device from delivering a shock during an emergency.
Product
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support…
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-1232-2014·2014-03-26
Philips Recalls HeartStart Home and OnSite AEDs Due to Solder Residue
Philips is recalling HeartStart Home and OnSite AEDs because solder residue may prevent the device from delivering therapy in an emergency.
Product
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2014·2014-03-26
Elekta Linear Accelerators Recalled for Default Value Reset Issues
Elekta, Inc. is recalling SL & SLi Series linear accelerators because customers are resetting default values outside recommended factory settings.
Product
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1238-2014·2014-03-26
Convatec SLC Foley Catheters Recalled for Blocked Lumens
Convatec Inc. is recalling 5,540 SLC 2-way Foley catheters because excess lubricious coating material was found blocking the lumen.
Product
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1266-2014·2014-03-26
Otto Bock Recalls Aerial Wheelchair Cushions Due to Flammability Risk
Otto Bock is recalling Aerial and Aerial Active wheelchair cushions because internal testing found a small risk of flammability after high-temperature washing.
Product
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1222-2014·2014-03-26
Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1240-2014·2014-03-26
Convatec Recalls Toray Hydrocoat Foley Catheters Due to Blocked Lumen
Convatec Inc. is recalling 54,590 Toray Hydrocoat Foley Catheters because the drainage lumen was found to be blocked by excess lubricious coating material.
Product
'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1223-2014·2014-03-26
Terumo Recalls Sarns Dual-stage Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1221-2014·2014-03-26
Terumo Recalls Sarns Venous Return Cannulae Due to Exposed Wire
Terumo CVS is recalling Sarns Malleable Dual-stage Venous Return Cannulae because in-process inspections found exposed basket wire on certain lots.
Product
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1263-2014·2014-03-26
Philips EPIQ 5 Ultrasound System Recalled for Incorrect Doppler Velocity Readings
Philips is recalling EPIQ 5 Ultrasound Systems because they may report incorrect Doppler velocities when using specific settings, potentially affecting diagnostic accuracy.
Product
Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1245-2014·2014-03-26
GE Healthcare Recalls CT Scanners Due to Head Scan Software Artifact
GE Healthcare is recalling Optima CT580 and Discovery CT590RT scanners running software version 13BW16.3 because a software issue may cause artifacts that hide pathology during head scans.
Product
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1176-2014·2014-03-19
Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk
Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.
Product
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1163-2014·2014-03-19
GE Healthcare Recalls Innova X-ray Systems for Unexpected Power Loss
GE Healthcare is recalling Innova cardiovascular X-ray systems because they may unexpectedly stop delivering X-rays, causing a loss of real-time imaging.
Product
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ; Cardiovascular X-ray imaging systems (X-ray generator installed with Rotor V3 version and Heater V4 version boards). The Digital Fluoroscopic Imaging System is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1168-2014·2014-03-19
Biomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure
Biomet 3i is recalling 170 Tapered Navigator Certain Surgical Kits because the trays failed to meet required sterility assurance levels during validation testing.
Product
Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1189-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.
Product
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile…
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1199-2014·2014-03-19
GE Healthcare Recalls Varicam and VG Hawkeye Imaging Devices
GE Healthcare is recalling Varicam and VG Hawkeye nuclear medicine devices due to a potential safety issue where the detector may drift toward the patient.
Product
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1165-2014·2014-03-19
Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy
Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.
Product
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1169-2014·2014-03-19
Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure
Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.
Product
Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1159-2014·2014-03-19
Smith & Nephew RENASYS-F XL Dressing Kits Recalled for Sealing Defects
Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.
Product
Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1167-2014·2014-03-19
Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure
Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.
Product
Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2014·2014-03-19
DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.
Product
REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to an issue with the plunger tip. The devices are sterile, single-use diagnostic tools used for drawing arterial blood.
Product
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood…
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-1161-2014·2014-03-19
Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues
Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.
Product
Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1162-2014·2014-03-19
Smith & Nephew RENASYS-AB Abdominal Dressing Kit Recall for Sealing Defects
Smith & Nephew is recalling RENASYS-AB Abdominal Dressing Kits because inadequate sealing may prevent fluid evacuation and fail to trigger pump alarms.
Product
Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1171-2014·2014-03-19
Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure
Biomet 3i is recalling 181 dental torque driver kits because they failed to meet required sterility assurance levels during validation testing.
Product
Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
Category
Medical Device
Distribution
Distributed nationwide

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25301–25325 of 27722