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

16351–16375 of 27500

HighFDA (Devices)·Z-0779-2019·2019-02-06
Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk
Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.
Product
Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0769-2019·2019-02-06
West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices
West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model used with oxytocin in pregnant women.
Product
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0788-2019·2019-02-06
GE Healthcare Recalls LOGIQ P6 Ultrasound Scanners Due to Probe Heating
GE Healthcare is recalling 1,897 LOGIQ P6 ultrasound scanners (Models BT07 and BT09) because the probe-head surface can reach increased temperatures during specific scans.
Product
GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0768-2019·2019-02-06
FDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events
West Pharma Services is recalling Vial2BAG Transfer Devices because adverse events were reported when used with oxytocin in pregnant women.
Product
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0786-2019·2019-02-06
Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects
Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.
Product
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0780-2019·2019-02-06
Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues
Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.
Product
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2019·2019-02-06
Siemens Atellica Analyzer Software Recall for Multiple System Issues
Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.
Product
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0791-2019·2019-02-06
3M Surgical Clipper Recalled for Overheating Risk During Charging
3M is recalling 19,860 Surgical Clippers due to reports of overheating when charging from modified sine wave power inverters in mobile EMS settings.
Product
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0778-2019·2019-02-06
Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage
Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.
Product
Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0781-2019·2019-02-06
Siemens Atellica Analyzer Software Recall for Multiple System Issues
Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.
Product
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0737-2019·2019-01-30
Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.
Product
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Medical Device
Distribution
12 states
SevereFDA (Drugs)·D-0383-2019·2019-01-30
Bound Tree Medical Recalls Epi Safe Kits Due to Incorrect Instructions
Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0753-2019·2019-01-30
Teleflex Percuvance Percutaneous Shaft Recall for Potential Tip Breakage
Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.
Product
Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0754-2019·2019-01-30
Teleflex Percuvance Percutaneous Shaft Recall Due to Tip Breakage Risk
Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.
Product
Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0739-2019·2019-01-30
Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.
Product
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Medical Device
Distribution
12 states
SevereFDA (Drugs)·D-0384-2019·2019-01-30
Recall of Curaplex Epi Safe Kits Due to Incorrect Epinephrine Instructions
Bound Tree Medical is recalling Curaplex Epi Safe Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Product
curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0756-2019·2019-01-30
Fetzer Medical Recalls Wrigley Obstetric Forceps Due to Functional Defect
Fetzer Medical is recalling 10 units of Wrigley Obstetric Forceps because doctors reported being unable to pull the instruments apart.
Product
12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0736-2019·2019-01-30
Draeger Medical Recalls VentStar Basic 180 Breathing Circuits
Draeger Medical is recalling 325 units of VentStar Basic 180 breathing circuits due to incorrect pre-assembly that may cause incorrect connections.
Product
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0757-2019·2019-01-30
Fetzer De Lee Obstetric Forceps Recalled Due to Functional Defect
Fetzer Medical is recalling 10 units of De Lee Obstetric Forceps because doctors reported being unable to pull the instruments apart.
Product
16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0738-2019·2019-01-30
Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 525 units of VentStar Basic (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection or short circuiting.
Product
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0740-2019·2019-01-30
Draeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 25 units of VentStar Watertrap (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection.
Product
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0771-2019·2019-01-30
Varian Eclipse Treatment Planning System Proton Algorithm Recall
Varian Medical Systems is recalling the Eclipse Treatment Planning System due to a software error in the Proton Convolution Superposition algorithm that miscalculates dose ranges for non-square CT images.
Product
Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0761-2019·2019-01-30
Stihler PRISMAFLO II Blood Return Warmer Recalled for Burn Risk
Stihler Electronic Gmbh is recalling PRISMAFLO II blood return warmers because damage to the heating profile may cause low-level skin burns.
Product
Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0772-2019·2019-01-30
Leica M220 F12 Surgical Microscope Recalled for Falling Optics Hazard
Leica Microsystems is recalling 15 Leica M220 F12 surgical microscopes because the optics may drop into the surgical field, risking contact with the patient.
Product
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2019·2019-01-30
Stihler PRISMAFLO II S Blood Return Warmer Recalled for Burn Risk
Stihler Electronic Gmbh is recalling PRISMAFLO II S blood return warmers because damage to the heating profile may cause low-level skin burns.
Product
Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Product Code: PF2-WP33 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
Category
Medical Device
Distribution
Distributed nationwide

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