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

37651–37675 of 40449

HighFDA (Devices)·Z-2091-2013·2013-09-04
Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure
Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.
Product
Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2115-2013·2013-09-04
GE Healthcare Recalls Dash Patient Monitors Due to Signal Noise
GE Healthcare is recalling Dash 3000, 4000, and 5000 patient monitors because movement of the ECG connector can cause intermittent noise on ECG and respiration waveforms, potentially reducing detection performance.
Product
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2013·2013-09-04
Integra Leyla Ball Joint Clamp Recalled for Potential Instability
Integra Limited is recalling 65 Leyla Ball Joint Clamps because they may not provide sufficient stability to maintain retraction during neurosurgery.
Product
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open…
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-2098-2013·2013-09-04
GE Ultrasound ViewPoint 6 Recalled for Incorrect Pulsatility Index Calculations
GE Healthcare is recalling 225 units of the ViewPoint 6 ultrasound system because it may incorrectly calculate venous flow measurements, potentially leading to false high-risk diagnoses for trisomy.
Product
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for a hip reconstruction prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox. Stem dia. 22.5 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2054-2013·2013-09-04
Stryker Recalls HydroSet Injectable HA Bone Substitute Due to Leaking Desiccant
Stryker is recalling HydroSet Injectable HA Bone Substitute kits because desiccant bags may leak silica gel, posing risks of foreign body reactions or increased anesthesia exposure.
Product
Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2084-2013·2013-09-04
Respironics V1000 Ventilator Recalled Due to Display Backlight Interruption
Respironics is recalling V1000 ventilators because power interruptions to the display backlight cause the screen to flicker or go dark, making it unreadable.
Product
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2066-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/25, Stem size 006, prox. Stem dia. 25 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2117-2013·2013-09-04
GE Healthcare Recalls TRAM Modules Due to ECG Signal Noise
GE Healthcare is recalling TRAM Modules because movement of the ECG connector causes signal noise, which may reduce the accuracy of ECG, respiration, and arrhythmia monitoring.
Product
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2013·2013-09-04
Roche Recalls ACCU-CHEK FastClix Lancing Devices Due to Needle Retraction Defect
Roche Diagnostics is recalling 36,332 ACCU-CHEK FastClix Lancing Devices because the needle may not fully retract after use, posing a puncture risk.
Product
ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2069-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Reconstruction Prosthesis
Waldemar Link is recalling nine trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/16, Stem size 02, prox. Stem dia. 16 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2105-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands that are subject to a separate recall by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design. The units were distributed only in Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2076-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling six trial stems for hip reconstruction prostheses because they were manufactured using the wrong design. The units were distributed only to Tennessee.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox. Stem dia. 16 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2095-2013·2013-09-04
Siemens Recalls Linear Accelerator Tabletops Due to Screw Breakage Risk
Siemens is recalling specific linear accelerator tabletops because manufacturing errors may cause screws to break off, potentially affecting patient safety.
Product
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2093-2013·2013-09-04
Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure
Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.
Product
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2071-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling five units of trial stems for hip reconstruction prostheses because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox. Stem dia. 20 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2086-2013·2013-09-04
Alphatec Recalls Illico Ti Cannulated Polyaxial Screws Due to Manufacturing Defect
Alphatec Spine is recalling specific lots of Illico Ti Cannulated Polyaxial Screws because an off-center hole may prevent guide wires from passing through during surgery.
Product
Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2013·2013-09-04
McKesson Anesthesia-Rx Software Recall Due to System Interruption
McKesson Technologies is recalling 106 Anesthesia-Rx units because the system became temporarily unavailable during use.
Product
Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2013·2013-09-04
DeRoyal Recalls Insufflation Tubing Sets Due to Materials Incompatibility
DeRoyal Industries is recalling specific lots of insufflation tubing sets because materials incompatibility could cause occlusion, potentially preventing gas flow during laparoscopic surgery.
Product
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2046-2013·2013-09-04
Nidek NAVIS-EX Image Filing Software Recalled for Eye Image Mislabeling
Nidek Inc is recalling NAVIS-EX software because left eye images may be incorrectly saved as right eye images.
Product
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2053-2013·2013-09-04
Sarken STAT! 1-Panel Test Kit Recalled for Inadequate Labeling
Sarken, Inc. is recalling STAT! 1-Panel Test Kits because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2050-2013·2013-09-04
Sarken THC Test Kits Recalled for Inadequate Labeling and Instructions
Sarken, Inc. is recalling SARKEN STAT! 1-Panel Test Kits-THC because they were distributed without adequate labeling and instructions, which could lead to misuse and incorrect results.
Product
SARKEN STAT! 1- Panel Test Kit-THC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2078-2013·2013-09-04
Waldemar Link Recalls Trial Stems for Hip Reconstruction Prosthesis
Waldemar Link is recalling 8 units of trial stems for the MP Reconstruction Prosthesis because they were manufactured using the wrong design.
Product
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/20, Stem size S-4, prox. Stem dia. 20 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
Category
Medical Device
Distribution
1 state

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37651–37675 of 40449