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

22451–22475 of 27663

HighFDA (Devices)·Z-0403-2016·2015-12-16
Olympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip
Olympus is recalling 182 ENDOEYE HD II video telescopes because a damaged temperature sensor can cause the tip to overheat, posing a burn risk to patients and users.
Product
Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0351-2016·2015-12-09
Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0354-2016·2015-12-09
Philips Xper Vascular System Monitor Ceiling Suspension Recall
Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2016·2015-12-09
Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0349-2016·2015-12-09
Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2016·2015-12-09
DeRoyal Recalls Neonatal Temperature Skin Sensors Due to Soldering Defect
DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.
Product
HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0356-2016·2015-12-09
Baylis ProTrack Microcatheter Recalled for Circumferential Shaft Cracks
Baylis Medical Corp is recalling 433 ProTrack Microcatheters nationwide due to circumferential cracks along the shaft.
Product
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0358-2016·2015-12-09
Carl Zeiss IOL Master 500 Software Recall for Incorrect IOL Power Data
Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.
Product
IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2016·2015-12-09
Philips BuckyDiagnost Patient Support Material Recall for Footplate Safety
Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.
Product
Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0348-2016·2015-12-09
Philips INTEGRIS Cardio System Ceiling Suspension Recall
Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2016·2015-12-09
Philips EasyDiagnost Patient Support Material Recalled for Footplate Safety Hazard
Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.
Product
Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0342-2016·2015-12-09
Medtronic InSync III Pacemaker Recall for Battery Impedance Issue
Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.
Product
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2016·2015-12-09
Philips Xper Vascular System Recall for Ceiling Suspension Fall Risk
Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0357-2016·2015-12-09
Carl Zeiss IOL Master 5.5 Software Recall for Incorrect Data
Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.
Product
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2016·2015-12-09
Philips Allura X-Ray System Ceiling Suspension Recall
Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0346-2016·2015-12-09
Philips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk
Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2016·2015-12-09
Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk
Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.
Product
Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2016·2015-12-09
Quest Medical MPS Delivery Sets Recalled for Intermittent Seal Failure
Quest Medical, Inc. is recalling specific MPS Delivery Sets used with cardiopulmonary bypass equipment due to intermittent seal failures during use.
Product
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0363-2016·2015-12-09
DeRoyal and GEO-MED sterile surgical kits recalled for seal defects
DeRoyal Industries is recalling 836 sterile custom surgical kits because a component may have packaging seal defects that compromise sterility.
Product
DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0344-2016·2015-12-09
Stryker Recalls I.V. Poles Due to Unexpected Retraction Hazard
Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.
Product
Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0271-2016·2015-12-02
Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation
Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.
Product
Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0337-2016·2015-12-02
NxStage Hemodialysis System Recalled for Ultrafiltration Volume Software Error
NxStage Medical is recalling 7 units of the System One S Cycler hemodialysis system due to a software error that may cause the pump to continue removing fluid after the target volume is reached.
Product
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0327-2016·2015-12-02
NxStage System One S Cycler Recalled for Ultrafiltration Software Error
NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.
Product
NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0331-2016·2015-12-02
Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect
Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.
Product
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2016·2015-12-02
Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias
Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.
Product
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
Category
Medical Device
Distribution
10 states

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22451–22475 of 27663