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

26401–26425 of 27686

HighFDA (Devices)·Z-1547-2013·2013-06-26
Biomet Recalls Phoenix Retrograde Femoral Connecting Bolts Due to Fit Issues
Biomet is recalling 75 Phoenix Retrograde Femoral Connecting Bolts because an undersized diameter may cause the hex driver to get stuck, delaying surgery.
Product
Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1551-2013·2013-06-26
GE Healthcare Recalls PET VCAR Software Due to Calculation Error
GE Healthcare is recalling PET VCAR software due to a potential safety issue with automated PERCIST response criteria calculations.
Product
GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1561-2013·2013-06-26
Linde Gas Recalls MEDICYL-e Portable Oxygen Systems Due to Valve Defect
Linde Gas North America is recalling MEDICYL-e Portable Oxygen Systems because some units may have misapplied valve flow knobs.
Product
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2013·2013-06-26
Philips BuckyDiagnost Radiographic Systems Recalled for Table Height Defects
Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.
Product
Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1546-2013·2013-06-26
Zimmer Patient Helper Bed Frame Adapter Assembly Recalled for Weak Welds
Zimmer, Inc. is recalling 344 Patient Helper Bed Frame Adapter Assemblies because they may have a weak weld where the mounting bars attach to the tube.
Product
Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1560-2013·2013-06-26
Tecan Freedom EVO Software Recall for Door Lock Safety Defect
Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.
Product
Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1436-2013·2013-06-19
Endologix AFX Introducer System Recalled for Dilator Breakage
Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.
Product
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1536-2013·2013-06-19
OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates
OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Product
90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1535-2013·2013-06-19
OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates
OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Product
90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1526-2013·2013-06-19
Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization
Bard Peripheral Vascular is recalling 815 UltraClip breast tissue markers because they were distributed without completing the sterilization process.
Product
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1534-2013·2013-06-19
OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates
OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
Product
90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1529-2013·2013-06-19
Bard Usher Support Catheters Recalled for Incomplete Sterilization
Bard Peripheral Vascular is recalling 223 Usher Support Catheters that were distributed without completing the sterilization process.
Product
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745 North Pastoria Ave, Sunnyvale CA 95085. The Usher¿ Peripheral is a single…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1528-2013·2013-06-19
Bard MicroSheath and Usher Catheters Recalled for Lack of Sterilization
Bard Peripheral Vascular is recalling 17 MicroSheath and Usher support catheters because they were distributed without completing the sterilization process.
Product
MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1542-2013·2013-06-19
Edwards Recalls QuickDraw Venous Cannula Due to Separation Complaints
Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.
Product
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1521-2013·2013-06-19
Applied Medical Recalls Epix and Direct Drive Laparoscopic Graspers
Applied Medical is recalling specific lots of Epix and Direct Drive Laparoscopic Graspers because the trigger may fracture, potentially leaving the jaws closed.
Product
Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1540-2013·2013-06-19
Abbott STAR S4 Excimer Laser System Recalled for Potential Inadvertent Firing
Abbott Medical Optics is recalling STAR S4 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.
Product
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1541-2013·2013-06-19
Abbott STAR S4 IR Excimer Laser System Recalled for Firing Risk
Abbott Medical Optics is recalling 1,882 STAR S4 IR Excimer Laser Systems worldwide due to an unlikely potential for inadvertent laser firing under specific conditions.
Product
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1539-2013·2013-06-19
Abbott STAR S3 Excimer Laser System Recalled for Firing Risk
Abbott Medical Optics is recalling STAR S3 Excimer Laser Systems due to an unlikely potential for inadvertent laser firing under specific conditions.
Product
STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1524-2013·2013-06-19
Bard UltraClip breast tissue marker recall due to separation risk
Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.
Product
BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1530-2013·2013-06-19
Ethicon Recalls Echelon 60mm Endoscopic Linear Cutter Reloads
Ethicon Endo-Surgery is voluntarily recalling Echelon 60mm endoscopic linear cutter reloads worldwide due to potential reload damage that could cause incomplete staple line formation.
Product
ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid. The ECHELON and ECHELON FLEX families of Endoscopic Linear Cutters (articulating and straight) are sterile, single patient use instruments that simultaneously cut and staple tissue.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1527-2013·2013-06-19
Bard UltraClip Breast Tissue Markers Recalled for Lack of Sterilization
Bard Peripheral Vascular is recalling 315 UltraClip breast tissue markers that were distributed without completing the sterilization process.
Product
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1520-2013·2013-06-19
DePuy Glenosphere Orientation Guide Recalled for Incorrect Etched Arrow Placement
DePuy Orthopaedics is recalling Glenosphere orientation guides because an etched arrow is on the wrong side, which could lead to incorrect implant alignment.
Product
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1462-2013·2013-06-12
Symbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump and GoBlock kits manufactured before July 2012 because they may deliver excessively high flow rates.
Product
Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr. Delivery time 60 to 144 hours; found in the following kits: GoBlock Kit 510646, Disposable Infusion Pump for drug delivery. Symbios GOBlock System is a disposable, self…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1456-2013·2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump kits because some units may deliver excessively high flow rates.
Product
Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " catheter & BIOPATCH GoPump Kit 510558-BP 10 " catheter& BIOPATCH GoPump Kit 64310 Disposable Single Infusion Pump. Symbios GOPump…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1454-2013·2013-06-12
Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.
Product
Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump…
Category
Medical Device
Distribution
Distributed nationwide

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26401–26425 of 27686