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

34526–34550 of 40325

HighFDA (Devices)·Z-0088-2015·2014-10-29
Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion
Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.
Product
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0116-2015·2014-10-29
Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts
Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.
Product
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-0090-2015·2014-10-29
Codman EDS 3 Drainage System Recalled for Tubing Leak Risk
Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.
Product
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0123-2015·2014-10-29
Zimmer Persona Tibial Articular Surface Inserter Recalled for Deformation Risk
Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter because they did not undergo heat treatment, creating a risk of tip deformation.
Product
The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0097-2015·2014-10-29
DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal
DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.
Product
Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0102-2015·2014-10-29
Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision
Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.
Product
Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0103-2015·2014-10-29
Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision
Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.
Product
ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0092-2015·2014-10-29
DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue
Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.
Product
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0113-2015·2014-10-29
Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues
Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.
Product
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0105-2015·2014-10-29
Philips Avalon Fetal Monitors Recalled for Software Measurement Error
Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.
Product
Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0104-2015·2014-10-29
Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage
Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.
Product
Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0094-2015·2014-10-29
Zimmer Recalls 19 Hip Prosthesis Shells Due to Missing Threads
Zimmer, Inc. is recalling 19 Continuum Acetabular System hip prosthesis shells because they are missing polar boss threads.
Product
Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0119-2015·2014-10-29
Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems
Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.
Product
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2015·2014-10-29
Ad-Tech Cueva Electrode Kits Recalled for Potential Wand Malfunction
Ad-Tech Medical Instrument Corporation is recalling Cueva Electrode Kits because the applicator wand may malfunction, potentially preventing monitoring of the VII cranial nerve.
Product
Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0121-2015·2014-10-29
Aerogen Nebulizer Power Adapter Recall Due to Broken Cover
Aerogen is recalling 323 FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover broke and dislodged from the adapter body.
Product
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0120-2015·2014-10-29
Aerogen Nebulizer Power Adapter Recall Due to Broken Cover
Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.
Product
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0117-2015·2014-10-29
Straumann Dental Implant Recall Due to Incorrect Component Assembly
Straumann USA is recalling 6 units of Bone Level Tapered Dental Implants because they were assembled with the wrong transfer piece.
Product
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0109-2015·2014-10-29
Signal Medical Recalls Microseal Hip Liners Due to Incorrect Dimensions
Signal Medical Corporation is recalling 12 Microseal Augmented acetabular liners because four units were found to have incorrect dimensions.
Product
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0111-2015·2014-10-29
Signal Medical Recalls Total Knee Femoral Components Due to Packaging Compromise
Signal Medical Corporation is recalling 41 Symmetric Total Knee Femoral Components because their packaging was compromised. The components were distributed in Missouri and Panama.
Product
Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0093-2015·2014-10-29
McKesson Cardiology Hemo Software Recall Due to Insufficient Maintenance Communication
McKesson Information Solutions LLC is recalling 625 McKesson Cardiology Hemo devices because communication regarding required annual maintenance testing was insufficient.
Product
McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0107-2015·2014-10-29
Mindray V-Series Patient Monitor Recalled for Drug Calculator Function Issue
Mindray DS USA is voluntarily recalling V-Series Patient Monitors due to a software issue with the Drug Calculator function.
Product
Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0114-2015·2014-10-29
Arrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components
Arrow International is recalling 300 units of an epidural anesthesia kit because the kit contains a Luer-Lock syringe instead of the labeled Luer-Slip syringe.
Product
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0108-2015·2014-10-29
St. Jude Medical Recalls Fast-Cath Trio Hemostasis Introducer Due to Dilator Defect
St. Jude Medical is voluntarily recalling 220 units of the Fast-Cath Trio Hemostasis Introducer because the dilator is too small to allow guidewire advancement, potentially causing procedural delays.
Product
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0099-2015·2014-10-29
Intra Pump Infusion Systems Recalls CRN Crono Syringes Due to Needle Debris
Intra Pump Infusion Systems is recalling CRN Crono Syringes because the needle tips may contain clear debris. The recall affects 25,440 units distributed in the US and Canada.
Product
CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0118-2015·2014-10-29
Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems
Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.
Product
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb…
Category
Medical Device
Distribution
Distributed nationwide

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