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

35226–35250 of 40325

ModerateFDA (Devices)·Z-2141-2014·2014-08-13
Ortho-Clinical Diagnostics Recalls VITROS 5600 Systems Due to Software Error
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because a software anomaly may associate incorrect patient demographics with sample IDs.
Product
VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2149-2014·2014-08-13
Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens is recalling 1,191 BNP immunoassay kits worldwide due to complaints of failed calibration. The kits are used for in vitro diagnostic testing.
Product
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2152-2014·2014-08-13
BioMerieux VIDAS TPSA Diagnostic Recalled for Unauthorized Distribution
BioMerieux SA is recalling 1,902 units of VIDAS TPSA in vitro diagnostic tests because the product is not approved or authorized for distribution in the US.
Product
VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2136-2014·2014-08-13
X Spine Systems Recalls Serrated Soft Tissue Shields for Spinal Surgery
X Spine Systems Inc is recalling Serrated Soft Tissue Shields from the Silex Sacroiliac Fusion System because Revision B is 7 mm longer than the previous design.
Product
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2144-2014·2014-08-13
Zimmer Recalls Tapered Screw-Vent Dental Implant Due to Labeling Error
Zimmer, Inc. is recalling Tapered Screw-Vent Dental Implants because the inner vial is labeled with incorrect dimensions.
Product
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2147-2014·2014-08-13
Boston Scientific recalls 21 ENDOTAK RELIANCE defibrillation leads due to test errors
Boston Scientific is recalling 21 ENDOTAK RELIANCE defibrillation leads because manufacturing test records showed suspected data recording errors. No injuries have been reported.
Product
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2150-2014·2014-08-13
Siemens ADVIA Centaur CP BNP Kit Recalled for Failed Calibration
Siemens Healthcare Diagnostics is recalling 961 BNP kits due to complaints of failed calibration. The kits are used for in vitro diagnostic testing of B-type Natriuretic Peptide.
Product
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2143-2014·2014-08-13
Carestream Recalls Ultra-speed Dental Film Due to Indicator Dot Misalignment
Carestream Health Inc. is recalling 1,633 boxes of Ultra-speed Dental Film because the indicator dot is incorrectly positioned, which may cause image orientation errors.
Product
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2154-2014·2014-08-13
Teleflex Recalls RUSCH Foley Urinary Catheter Insertion Trays Due to Labeling Error
Teleflex Medical is recalling 720 RUSCH Foley Urinary Catheter Insertion Trays because the expiration date is incorrectly printed as the same as the manufacturing date.
Product
RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2142-2014·2014-08-13
Carestream Recalls INSIGHT Dental Film Due to Indicator Dot Misplacement
Carestream Health Inc. is recalling INSIGHT Dental Film because the indicator dot on the packaging is misaligned, which may cause dental practitioners to view images upside down.
Product
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2112-2014·2014-08-06
Wellspring Recalls IPM Wound Gel Rx Wound Dressing Due to Microbial Contamination
Wellspring Pharmaceutical is recalling IPM Wound Gel Rx Wound Dressing due to a potential for microbial contamination. The product is distributed in the US and Canada.
Product
IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-2122-2014·2014-08-06
Stryker InTouch Critical Care Bed Recall Due to Caster Failure
Stryker is recalling InTouch Critical Care Beds because casters may break and fall off, potentially affecting brake functions.
Product
InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2014·2014-08-06
Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure
Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.
Product
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2118-2014·2014-08-06
Medtronic Nexdrive Micropositioning Drive Recalled for Potential Misalignment
Medtronic is recalling Nexdrive Micropositioning Drives because a scale misalignment could cause microelectrodes to be inserted at incorrect depths during surgery.
Product
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-2123-2014·2014-08-06
Ra Medical Systems Recalls PHAROS EX-308 Excimer Lasers Due to Calibration Defect
Ra Medical Systems is recalling 435 PHAROS EX-308 Excimer Lasers because they may calibrate with the iris closed.
Product
PHAROS Excimer Laser, Model No. EX-308 UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis and leukoderma
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2014·2014-08-06
Teleflex Recalls RUSCH TruLite Disposable Laryngoscope Handles
Teleflex Medical is recalling RUSCH TruLite laryngoscope handles because the handle may heat up and melt the end cap.
Product
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Distributed by: Teleflex Medical.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2014·2014-08-06
Baxter Recalls FlowCOUPLER Implantable Devices for Potential Signal Loss
Baxter Healthcare is recalling 1,315 FlowCOUPLER implantable devices because some units may lose electrical continuity, preventing proper monitoring of blood flow.
Product
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2124-2014·2014-08-06
DeRoyal Knee Arthroscopy Pack Recalled Due to Component Recall
DeRoyal Industries is recalling 128 Knee Arthroscopy Packs because they contain Irrigation Sets previously recalled by Hospira.
Product
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2117-2014·2014-08-06
Dynarex CPR Shield Recalled for Incorrect Orientation Labeling
Dynarex Corporation is recalling CPR Shields with One Way Valves because the 'THIS SIDE UP' label is on the wrong side, posing a potential health hazard if misused.
Product
CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2121-2014·2014-08-06
McKesson Horizon Medical Imaging Software Recalled for Image Index Discrepancy
McKesson Medical Imaging is recalling Horizon Medical Imaging software due to a defect that may cause a mismatch between the expected image index and the actual folder content.
Product
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical…
Category
Medical Device
Distribution
48 states
ModerateFDA (Devices)·Z-2119-2014·2014-08-06
Teleflex Medical Recalls Emerald Fiberoptic Blades Due to Packaging Error
Teleflex Medical is recalling 120 units of Emerald Fiberoptic Blades because the boxes contained incorrect Miller 4 blades instead of the labeled Macintosh 4 blades.
Product
Emerald Fiberoptic Blade, Macintosh 4, Teleflex Medical. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-2125-2014·2014-08-06
DeRoyal Cardiac Hypothermia Tray Recalled Due to Contaminated Irrigation Sets
DeRoyal is recalling Cardiac Hypothermia Trays because they contained irrigation sets previously recalled by Hospira.
Product
DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2132-2014·2014-08-06
Nidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc. is recalling 29 MC-500 Multicolor Laser Photocoagulators because the laser aperture label was not affixed to the devices prior to shipment.
Product
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2134-2014·2014-08-06
Brainlab Patient Data Manager 2.0 Software Recall for Image Display Defects
Brainlab AG is recalling Patient Data Manager 2.0 software due to defects in transferring and displaying non-square pixel medical images.
Product
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2127-2014·2014-08-06
Small Bone Innovations Recalls AutoFIX Cannulated Compression Screw Systems for IFU Update
Small Bone Innovations is recalling 506 units of 3.0/4.0mm AutoFIX Cannulated Compression Screw Systems to update the Instructions for Use (IFU).
Product
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as…
Category
Medical Device
Distribution
Distributed nationwide

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35226–35250 of 40325