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 deaths or serious injuries are reported, 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

6801–6825 of 13512

HighFDA (Devices)·Z-1337-2024·2024-03-27
Guidewire Introducer Recalled for Manufacturing Defect Affecting Device Function
Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1330-2024·2024-03-27
Laparotomy Sponges recalled for incomplete sterilization and missing RF detection
Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.
Product
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1310-2024·2024-03-27
ECMO heat exchanger module recalled due to water path restriction
Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.
Product
NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1332-2024·2024-03-27
Directional Laser Probe Recall Due to Fiber Extension and Direction Malfunction
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
Product
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1341-2024·2024-03-27
Angiodynamics Guidewire Introducer Recall Due to Manufacturing Defect
Angiodynamics recalls approximately 5,840 guidewire introducers with manufacturing defects that may prevent proper guidewire insertion during vascular procedures. The defect could cause procedural delays requiring equipment exchange.
Product
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1329-2024·2024-03-27
Hip Traction Boot Assembly Defect Could Cause Device Detachment
Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.
Product
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2024·2024-03-27
Directional Laser Probe Recalled for Fiber Extension and Direction Failure
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Product
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2024·2024-03-27
Convatec EsteemBody Drainable Pouches Recalled for Filter Weld Defect
ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistency in filter weld strength, affecting 6709 units distributed in the US and internationally.
Product
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, h) 423657, i) 423652, j) 423646, k) 423654, l) 423653, m) 423647, n) 423644, o) 423648, p) 423665, q) 423656, r) 423651, s) 423660,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2024·2024-03-27
Access Total T4 thyroxine assay recalled for test imprecision
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.
Product
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1322-2024·2024-03-27
Dental Implant Impression Coping Recalled for Manufacturing Defect
Thommen Medical AG is recalling impression coping units because the internal canal depth was not manufactured according to specifications, preventing firm connection to the dental implant. The product was distributed in Ohio and Kentucky.
Product
impression coping, repositionable, short, screw-retained, PF 4.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1348-2024·2024-03-27
Guidewire Introducer Sheath Recalled for Internal Lumen Voids
Angiodynamics is recalling 39 units of MINI STICK MAX vascular guidewire introducers due to voids in the sheath hub that may prevent guidewire passage during surgery, potentially delaying the procedure.
Product
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1342-2024·2024-03-27
Surgical Guidewire Introducer Sheath Recalled for Internal Manufacturing Defects
Angiodynamics vascular guidewire introducers (600 units) may have internal defects preventing proper function during surgery. Defects could cause procedure delays and require device exchange.
Product
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1347-2024·2024-03-27
Vascular guidewire introducer recalled for manufacturing defect causing procedural delays
Angiodynamics recalls the MINI STICK MAX vascular guidewire introducer due to internal defects in the sheath hub that may prevent guidewire insertion during surgery, potentially requiring equipment exchange.
Product
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1345-2024·2024-03-27
MINI STICK MAX guidewire introducer defect may prevent sheath passage during procedures
Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2024·2024-03-27
Medical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.
Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1319-2024·2024-03-27
I.B.S. 6.5-C Compression Screw Batch Recalled for Dimensional Mix-Up
A batch of I.B.S compression screws may have incorrect dimensions compared to their labels due to a batch mix-up. The 59 affected units were distributed nationwide in Tennessee.
Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2024·2024-03-27
Abbott Point of Care Control Device Recalled Due to Temperature Storage Failure
Abbott's i-STAT Level 1 control device is recalled because a refrigerator temperature excursion on January 8, 2024, could cause incorrect or delayed test results. The walk-in storage unit failed, causing temperatures to fall below the required range of 35.6-46.4°F.
Product
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1334-2024·2024-03-27
Vascular guidewire introducer recalled for manufacturing defect
Angiodynamics recalls MINI STICK MAX vascular guidewire introducers due to internal lumen defects that may prevent the guidewire from passing through during surgery, potentially requiring device exchange.
Product
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1343-2024·2024-03-27
Vascular Guidewire Introducer Sheath Recalled for Internal Hub Defect
Angiodynamics recalls 130 MINI STICK MAX guidewire introducers due to hub voids that may prevent guidewire passage during vascular procedures. No injuries reported.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1338-2024·2024-03-27
Vascular Guidewire Introducer Sheath Recall Due to Manufacturing Defect
Angiodynamics is recalling certain MINI STICK MAX vascular guidewire introducer sheaths due to internal voids that may prevent guidewire passage during surgery, potentially causing procedural delays.
Product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1313-2024·2024-03-27
Steris Endo Cleaning Indicator Recalled Due to Temperature Excursion
Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.
Product
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1349-2024·2024-03-27
Landauer microStar Reader dosimetry system discontinued for medical applications
Landauer is permanently discontinuing the microStar Reader medical dosimetry system. The company is removing product documentation references and discontinuing use with medical dosimeters.
Product
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1316-2024·2024-03-27
Medtronic DLP Vessel Cannula Recalled for Incorrect Labeling
Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.
Product
Medtronic DLP Vessel Cannula, Model Number REF 30000
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1315-2024·2024-03-27
Laboratory Control Material Recalled Due to Temperature Storage Excursion
Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.
Product
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1328-2024·2024-03-27
Liquid Protein Calibrators recalled for reference material realignment correction
Randox Laboratories is recalling 1,764 units of Liquid Protein Calibrators used in immunoassays due to realignment of C3 and Haptoglobin to the correct reference material standard. Distribution was limited to seven U.S. states.
Product
Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
Category
Medical Device
Distribution
7 states

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6801–6825 of 13512