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

20276–20300 of 27682

HighFDA (Devices)·Z-1134-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.
Product
Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2017·2017-02-08
Siemens Recalls IMMULITE PSA Kits Due to Negative Bias
Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.
Product
IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1112-2017·2017-02-08
Implant Direct Recalls SwishTapered Implants Due to Packaging Error
Implant Direct Sybron Manufacturing is recalling 17 SwishTapered Implants because the packaged extender was in the incorrect position, which may cause micro-leakage and infection.
Product
SwishTapered Implant
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1130-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling 185 units of Intact Disposable Wands because the sterile barrier was breached, compromising sterility.
Product
Intact Disposable Wands (part of the Intact System) 900-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2017·2017-02-08
Medtronic Intact Disposable Wands Recalled for Sterility Compromise
Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 320 units distributed worldwide.
Product
Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0923-2017·2017-02-01
Philips Allura Xper FD10 X-ray System Recalled for Loose Screws
Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.
Product
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1065-2017·2017-02-01
Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.
Product
Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-1063-2017·2017-02-01
Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk
Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.
Product
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0925-2017·2017-02-01
Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws
Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.
Product
Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1064-2017·2017-02-01
Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.
Product
Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0924-2017·2017-02-01
Philips Allura Xper FD20 C-arm Recall Due to Loose Screws
Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.
Product
Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1099-2017·2017-02-01
Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors
Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.
Product
Accu-Chek Connect Diabetes Management App
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1066-2017·2017-02-01
Villa Radiology Systems Recalls Apollo EZ X-Ray Systems Due to Injury Risk
Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.
Product
Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Category
Medical Device
Distribution
26 states
SevereFDA (Devices)·Z-0922-2017·2017-02-01
Philips Allura Xper FD20 C-arm Recall for Loose Screws
Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.
Product
Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1097-2017·2017-02-01
Softbank II Transfusion Software Recalled for Potential Incorrect Results
Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.
Product
SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1077-2017·2017-02-01
Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue
Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.
Product
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2017·2017-02-01
INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration
INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.
Product
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and…
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1095-2017·2017-02-01
Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits
Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.
Product
Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1074-2017·2017-02-01
Medline Recalls Unna-Z Compression Wraps Due to Mold Contamination
Medline Industries is recalling Unna-Z compression wraps due to contamination with common mold species. The recall affects units distributed in the US and several international countries.
Product
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2017·2017-02-01
Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging
Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.
Product
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2017·2017-02-01
Softbank Transfusion Software Recalled for Potential Incorrect Results
Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.
Product
Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2017·2017-02-01
Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue
Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.
Product
Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help re-establish lung expansion and restore breathing dynamics. To facilitate postoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1061-2017·2017-02-01
Philips Recalls Velara Generators Due to Potential System Lockup
Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.
Product
Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-1106-2017·2017-02-01
Philips Cisco 3850 Switch Recall Due to Monitoring Loss Risk
Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.
Product
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1083-2017·2017-02-01
Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging
Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.
Product
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum. To help…
Category
Medical Device
Distribution
Distributed nationwide

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20276–20300 of 27682