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

16701–16725 of 27500

SevereFDA (Devices)·Z-0181-2019·2018-10-24
OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies
OriGen Biomedical is recalling 435 Reinforced Dual Lumen Cannulas because they may lack barium sulfate and have tips shorter than labeled.
Product
Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0178-2019·2018-10-24
Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.
Product
Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2019·2018-10-24
Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk
Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.
Product
Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0173-2019·2018-10-24
Life Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps
Life Technologies is recalling 41 units of Gibco Sodium Pyruvate (100 mM) because defective bottle caps may compromise product sterility.
Product
Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0148-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 29 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0139-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 24 units of Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.
Product
Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2019·2018-10-24
Mindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies
Mindray is recalling five BeneVision Distributed Monitoring Systems due to a software issue that can cause ECG waveforms to display as a flat line when more than 64 telemetry transmitters are connected.
Product
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0131-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0183-2019·2018-10-24
OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies
OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.
Product
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0111-2019·2018-10-24
GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled
GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.
Product
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0164-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.
Product
Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0174-2019·2018-10-24
Life Technologies Recalls Gibco GlutaMAX Supplement Due to Leaky Bottles
Life Technologies is recalling 1,912 units of Gibco GlutaMAX Supplement because defective bottle caps may compromise the product's sterility.
Product
Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.
Product
Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0152-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 60 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 38 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.
Product
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues
Zimmer Biomet is recalling 32 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.
Product
Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2019·2018-10-24
Philips HeartStart FR3 Defibrillators Recalled for Water Ingress Risk
Philips is recalling 432 HeartStart FR3 defibrillators because they may not meet water resistance specifications, potentially causing device failure if water enters.
Product
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2019·2018-10-24
Recall of Affixus Hip Fracture Nail Over Sterility Issue
Zimmer Biomet is recalling the Affixus Hip Fracture Nail because sterile packaging was found already open during surgery. The affected lot was distributed in the US and internationally.
Product
Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0116-2019·2018-10-24
Siemens Atellica IM CKMB Calibrator Recalled for Potential Bias
Siemens Healthcare Diagnostics is recalling 97 kits of Atellica IM CKMB Calibrator due to a potential bias compared to internal standards.
Product
Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect
Zimmer Biomet is recalling 31 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0112-2019·2018-10-24
GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch
GE Medical Systems is recalling 5,200 MRI systems worldwide because software issues may cause flipped images or patient data mismatches.
Product
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0159-2019·2018-10-24
Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects
Zimmer Biomet is recalling 39 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.
Product
Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

16701–16725 of 27500