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

25376–25400 of 40233

HighFDA (Devices)·Z-0208-2018·2017-12-13
Intersurgical Solus Flexible Laryngeal Mask Airways Recalled for Occlusion Risk
Intersurgical Inc is recalling Solus Flexible wire-reinforced laryngeal mask airways because a defect in the tubing may cause partial or total occlusion when the cuff is over-inflated.
Product
Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0211-2018·2017-12-13
Biosense Webster Recalls PENTARAY NAV High-Density Mapping Catheters
Biosense Webster is recalling PENTARAY NAV High-Density Mapping Catheters because the instructions for use were updated to indicate they should not be used in patients with prosthetic valves.
Product
PENTARAY NAV High-Density Mapping Catheter.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0199-2018·2017-12-13
DeRoyal Surgical Kits Recalled for Incorrect Expiration Date on Prep Pads
DeRoyal is recalling sterile custom surgical kits containing Medline Aplicare Povidone Iodine Prep Pads due to incorrect expiration dates.
Product
DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0206-2018·2017-12-13
Novo Nordisk Recalls Dial-A-Dose Insulin Pen Cartridge Holders
Novo Nordisk is recalling specific batches of Dial-A-Dose insulin pen cartridge holders because they may crack or break when exposed to certain cleaning agents.
Product
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0209-2018·2017-12-13
Remel Mueller-Hinton Broth Recalled for Incorrect Cation Labeling
Remel Inc is recalling 7 units of Mueller-Hinton Broth IVD because the product label may contain incorrect cation information.
Product
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-0201-2018·2017-12-13
Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch
Exactech, Inc. is recalling nine Vantage Total Ankle Tibial Inserts because the inner labeling and packaged device may not match the outer box label.
Product
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0204-2018·2017-12-13
FDA Recalls Two Unapproved Morning Life Air Compression Devices
Won Industry Co. is recalling two Morning Life air compression devices because they were distributed without FDA approval and have incorrect air compression settings.
Product
Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0200-2018·2017-12-13
Exactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch
Exactech is recalling nine Vantage Total Ankle Tibial Inserts due to possible mismatches between inner and outer packaging labels.
Product
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0203-2018·2017-12-13
Fukuda Denshi Patient Monitor Recall for Damaged Lithium-Ion Capacitor
Fukuda Denshi is recalling DS-8100M and DS-8100N patient monitors because a damaged lithium-ion capacitor may cause a short-term battery error message.
Product
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0212-2018·2017-12-13
Biosense Webster Recalls PENTARAY NAV Mapping Catheters Due to Labeling Update
Biosense Webster is recalling 73,796 PENTARAY NAV High-Density Mapping Catheters to update contraindication language in the Instructions For Use regarding prosthetic valves.
Product
PENTARAY NAV High-Density Mapping Catheter.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0198-2018·2017-12-13
BD Phoenix AP Instrument Recalled for Potential Robot Arm Movement
Becton Dickinson & Co. is recalling seven BD Phoenix AP instruments due to a potential for unexpected robot arm movement.
Product
BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required…
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0590-2018·2017-12-13
C.R. Bard Recalls Arctic Sun ArcticGel Pads Due to Labeling Error
C.R. Bard is recalling 128 units of Arctic Sun ArcticGel Pads - Medium because the product box displays an incorrect reference number.
Product
Arctic Sun ArcticGel Pads - Medium, Product Code 317-07
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0175-2018·2017-12-06
Siemens Dimension Vista Protein 1 Control M Recalled for Inaccurate Ceruloplasmin Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.
Product
Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0171-2018·2017-12-06
BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures
Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.
Product
BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0178-2018·2017-12-06
Zimmer Biomet Recalls ROSA Surgical Device 2.5.8 Units
Zimmer Biomet is recalling 22 ROSA Surgical Device 2.5.8 units due to an issue with the optional neuro-endoscopy module detected during internal testing.
Product
ROSA Surgical Device 2.5.8
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0192-2018·2017-12-06
Hill-Rom Recalls Monarch Airway Clearance Systems Due to EMI Risk
Hill-Rom is recalling 60 Monarch Airway Clearance Systems because electromagnetic interference may disrupt implanted pacemakers or defibrillators.
Product
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2018·2017-12-06
Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error
Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.
Product
BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0174-2018·2017-12-06
Siemens Dimension Vista Protein 1 Control Recalled for Inaccurate Ceruloplasmin Assignment
Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall below the reference range.
Product
Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0189-2018·2017-12-06
Volcano Imaging Systems Recalled Due to Unexpected Windows Security Dialog
Volcano Corporation is recalling specific intravascular ultrasound imaging systems because an unexpected Microsoft Windows Security dialog may appear during use, potentially affecting device operation.
Product
Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0184-2018·2017-12-06
Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue
Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.
Product
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0181-2018·2017-12-06
Arrow PICC Kits Recalled for Potential Incorrect Sheath Size
Arrow International is recalling specific PICC kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.
Product
ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0183-2018·2017-12-06
BD Insulin Syringes Recalled for Incorrect Needle Length Labeling
Becton Dickinson is recalling specific lots of BD Insulin Syringes because some polybags were mislabeled with the wrong needle length and gauge.
Product
BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0190-2018·2017-12-06
Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration
CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.
Product
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0173-2018·2017-12-06
Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results
Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.
Product
Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0182-2018·2017-12-06
Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error
Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.
Product
ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast…
Category
Medical Device
Distribution
Distributed nationwide

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25376–25400 of 40233