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

15501–15525 of 40112

HighFDA (Devices)·Z-0765-2021·2021-01-06
BD Phoenix PMIC-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC-109 in vitro diagnostic devices because they may produce false resistant results for S. aureus, potentially affecting antibiotic treatment choices.
Product
BD Phoenix" PMIC-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448419
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0754-2021·2021-01-06
Roche cobas 8000 Modular Analyzer Recall for Potential Configuration Errors
Roche is recalling cobas 8000 modular analyzers because configuration settings may change, causing incorrect results that could go undetected.
Product
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0753-2021·2021-01-06
Intersurgical Smoothbore Breathing System Recalled for Incorrect Exhalation Port
Intersurgical Inc is recalling 200 Smoothbore breathing systems with exhalation port 22 mm because they were assembled with the incorrect port, which can cause gas leakage.
Product
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0757-2021·2021-01-06
Boston Scientific Recalls Contour VL Ureteral Stents Due to Nickel Debris
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.
Product
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0738-2021·2021-01-06
Medtronic Ares Antibiotic-Impregnated Catheter Recall for Seal Defect
Medtronic is recalling Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase the risk of post-operative infection.
Product
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0749-2021·2021-01-06
Merit Medical Systems Recalls Custom Angiography Kits with Sealing Defects
Merit Medical Systems is recalling 90 custom angiography kits because header bags may not be fully sealed, potentially compromising the sterile barrier and leading to infection.
Product
Product Code: K05T-02533, Custom Inflation Kit, Custom K05 Sterile EO, Rx Only, (01)00884450255803 For Angiography/angioplasty. The contents of the kit include surgical drapes, towels, medicine cups, needles, various bowls, pen and label sets (PAL), scalpel, several…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0739-2021·2021-01-06
Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect
Medtronic is recalling 1,926 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Product
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0745-2021·2021-01-06
Westmed Adult Elongated Oxygen Mask Recalled for Loose Fitment
Westmed is recalling 16,000 adult elongated oxygen masks because the tube connection may become loose, potentially delaying oxygen therapy.
Product
REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0759-2021·2021-01-06
BD Phoenix PMIC/ID-105 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-105 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-105: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448605 (Discontinued)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0744-2021·2021-01-06
Westmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment
Westmed is recalling 1,200 units of Adult CO2/O2 Masks because the oxygen delivery tube may become loose, potentially delaying treatment.
Product
REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0762-2021·2021-01-06
BD Phoenix PMIC/ID-108 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-108 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448608
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0751-2021·2021-01-06
Merit Medical Systems Recalls Cardiac Catheterization Kits Due to Sterility Concerns
Merit Medical Systems is recalling 80 cardiac catheterization kits because header bags may not be fully sealed, potentially compromising sterility and increasing infection risk.
Product
Custom Procedure Kit, Cardiac Cath Pack, Product Code: K12T-10996 Rev. B, Sterile EO, Rx Only, (01)00884450515105 For Angiography/angioplasty. The contents of the kit are surgical drapes, gowns, towels, medicine cups, needles, various bowls, pen and label set (PAL), scalpel…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0746-2021·2021-01-06
Westmed Adult Oxygen Mask Recall Due to Potential Loose Fitment
Westmed is recalling 6,000 units of Adult Elongated O2/CO2 Masks because the oxygen delivery tube may not connect securely to the mask adapter, potentially delaying treatment.
Product
REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, Rx Only, CE0482, (01)00709078001697 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0737-2021·2021-01-06
ROi CPS Recalls Custom Procedure Packs with Flaking Gauze Sponges
ROi CPS LLC is recalling 17,700 custom procedure packs because the gauze sponges inside may be flaking or fraying.
Product
Custom procedure packs, containing banded 4x4 Raytec 16ply gauze sponges. 1) Regard, PACEMAKER, Item 800221010, Lot # 82466. 2) Regard, BASIC, Item 800109003 Lot # 83411. 3) Regard, MAJOR EAR, Item 800070009, Lot # 82442. 4) Regard, NEURO, Item 800040011, Lot # 82504.…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0764-2021·2021-01-06
BD Phoenix PMIC/ID-109 Recalled for False SXT Resistance Results
Becton Dickinson is recalling BD Phoenix PMIC/ID-109 because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448609
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0742-2021·2021-01-06
Westmed Non-Rebreather Masks Recalled for Loose Oxygen Tube Fitment
Westmed is recalling 37,300 non-rebreather masks because the oxygen tube connection may become loose, potentially delaying patient treatment.
Product
Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Only, CE0482, (01)10709078008020 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0740-2021·2021-01-06
Medtronic Ares Antibiotic-Impregnated Catheter Recalled for Seal Defect
Medtronic is recalling 3,858 Ares Antibiotic-Impregnated Catheters due to a potential seal defect that may compromise sterility and increase infection risk.
Product
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0763-2021·2021-01-06
BD Phoenix PMIC-108 Recalled for False SXT Resistance Results
Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective antibiotic treatment.
Product
BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448418
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0758-2021·2021-01-06
Boston Scientific Recalls Contour VL Ureteral Stent Sets Due to Nickel Debris
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.
Product
Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0760-2021·2021-01-06
BD Phoenix PMIC/ID-107 Recalled for False SXT Resistance Results
Becton Dickinson is recalling the BD Phoenix PMIC/ID-107 in vitro diagnostic device because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.
Product
BD Phoenix PMIC/ID-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448607
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0743-2021·2021-01-06
Westmed Adult Elongated CO2/O2 Mask Recall for Loose Fitment
Westmed is recalling 600 units of Adult Elongated CO2/O2 Masks because the tubing connection may become loose, potentially delaying oxygen therapy.
Product
REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' GSL X .038" ID X .107" OD, Reflective Luer Connectors, Rx Only, CE0482, (01)00709078005718 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0755-2021·2021-01-06
Roche cobas pro integrated solutions recalled for potential incorrect results
Roche Diagnostics is recalling 7 cobas pro integrated solutions units because configuration settings may cause incorrect clinical results that remain undetected.
Product
Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0752-2021·2021-01-06
Roche cobas c 503 Analyzer Recalled for Inaccurate Test Results
Roche Diagnostics is recalling cobas c 503 analyzers and kits because residual reagent transfer can cause inaccurately low results for therapeutic drug monitoring tests.
Product
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0726-2021·2021-01-06
Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error
Smiths Medical is recalling 238 Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Product
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0756-2021·2021-01-06
Lidco CM 50-001-01 Injectate Kit Recalled for Incorrect Expiration Date
Lidco Ltd is recalling specific lots of the CM 50-001-01 Injectate Kit because the expiration date on the labeling is incorrect.
Product
CM 50-001-01 Injectate Kit, accessory device to LiDCOunity v2 Monitor - Product Usage: intended to administer lithium dilution indicator (tube administrative set).
Category
Medical Device
Distribution
Distributed nationwide

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15501–15525 of 40112