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

33451–33475 of 40449

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
HighFDA (Devices)·Z-1266-2015·2015-03-18
Zimmer Persona Trabecular Metal Tibial Plate Recall for Loosening Complaints
Zimmer, Inc. is recalling Persona Trabecular Metal Tibial Plates due to increased complaints of loosening and radiolucent lines.
Product
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-1262-2015·2015-03-18
Medela Recalls Sterile Enteral Feeding Syringes Due to Packaging Breach
Medela Inc. is recalling sterile enteral feeding syringes because a potential packaging breach may have compromised their sterility.
Product
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1259-2015·2015-03-18
Arrow Intra-Aortic Balloon Catheter Kit Recalled for Potential Helium Leak
Arrow International Inc is recalling 166 units of Intra-Aortic Balloon Catheter Kits due to a potential leak that allows helium to escape.
Product
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1252-2015·2015-03-18
Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability
Siemens is recalling 3,420 RAPIDPoint 405 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
Product
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784. These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1265-2015·2015-03-18
Southern Implants Recalls Dental Implants Due to Labeling Mismatch
Southern Implants, Inc. is recalling 130 units of MAX-TL and Z-MAX dental implants because the labeled packages contained the wrong implant type.
Product
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1255-2015·2015-03-18
Siemens RAPIDLab 1265 System Recalled for Neonatal Bilirubin Variability
Siemens Healthcare Diagnostics Inc is recalling 2,863 RAPIDLab 1265 Systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
Product
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1253-2015·2015-03-18
Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Neonatal Bilirubin Variability
Siemens is recalling 4,376 RAPIDPoint 500 Blood Gas Analyzers worldwide because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
Product
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306. The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1254-2015·2015-03-18
Siemens RapidLab 1245 System Recalled for Neonatal Bilirubin Variability
Siemens is recalling 241 RapidLab 1245 systems because the neonatal bilirubin parameter may show increased variability under specific high-concentration conditions.
Product
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1263-2015·2015-03-18
Ortho-Clinical VITROS Hand-held Barcode Scanner Recall for Sample Skipping
Ortho-Clinical Diagnostics is recalling VITROS Hand-held Barcode Scanners because they may skip sample cup positions when using the Batch Programming option.
Product
VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1264-2015·2015-03-18
Richard-Allan Scientific Recalls Mislabelled CYTO-STAIN R Stain Bottles
Richard-Allan Scientific is recalling 132 gallons of CYTO-STAIN R Stain because the bottles were incorrectly labeled as CYTO-STAIN G, although the contents are correct.
Product
Carton: Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle: Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1240-2015·2015-03-11
Richard Wolf I-Cart Medical Video Equipment Recall for Overheating Transformers
Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units because transformers may overheat, causing smoke and black plastic material to leak from the chassis.
Product
The I-Cart is used to store, transport, and power video equipment used in medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1209-2015·2015-03-11
Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters
Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.
Product
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1242-2015·2015-03-11
Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters
Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.
Product
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2015·2015-03-11
Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices
Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.
Product
Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2015·2015-03-11
Philips Allura Xper X-Ray Angiographic Software Recall
Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.
Product
Philips Medical System Allura Xper X-Ray Angiographic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2015·2015-03-11
Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices
Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.
Product
Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1243-2015·2015-03-11
iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.
Product
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1224-2015·2015-03-11
Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect
Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.
Product
Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1235-2015·2015-03-11
Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns
Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.
Product
Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1220-2015·2015-03-11
Halyard Health Recalls KimVent Closed Suction Systems Due to Defects
Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.
Product
KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1221-2015·2015-03-11
Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect
Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.
Product
KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
Category
Medical Device
Distribution
11 states

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33451–33475 of 40449