FDA & USDA Recalls

Search recalls and safety alerts across food, drugs, medical devices, cosmetics, and meat/poultry

Refresh Data
📊 Total Tracked Records by Product Type
🍕 Food
28,882
recalls
💊 Drugs
17,632
recalls
🏥 Devices
38,745
recalls
💄 Cosmetics
85,511
events
🚬 Tobacco
1,286
events
🐾 Veterinary
1,299,110
events
Current View: Medical Devices • Showing 50 recalls
Angio Packs (AMS6908E and AMS6908F)
RECALLWebsite NoticeOngoing
Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism.
Date: 04-19-2026|Location: N/A
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
RECALLClass IIOngoing
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Date: 03-27-2026|Location: N/A|Recall No: Z-1918-2026
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
RECALLClass IIOngoing
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds. Cross-reactivity may result in the misidentification of a Salmonella 9-O serotype as a 2-O serotype.
Date: 03-25-2026|Location: N/A|Recall No: Z-1923-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1909-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1908-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1907-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1905-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1904-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
RECALLClass IIOngoing
XXX
Date: 03-25-2026|Location: N/A|Recall No: Z-1903-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1902-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1901-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1900-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1899-2026
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.
RECALLClass IIOngoing
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Date: 03-25-2026|Location: N/A|Recall No: Z-1898-2026
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.
RECALLClass IIOngoing
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Date: 03-25-2026|Location: N/A|Recall No: Z-1896-2026
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx (F1CDx) installed on Research Triangle Park laboratory Equipment IDs 01342, 01591, 01989, 01990, 01994, 01995.
RECALLClass IIOngoing
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Date: 03-24-2026|Location: N/A|Recall No: Z-1937-2026
Yeastone Broth, 11ML, 10/BOX YY3462
RECALLClass IIOngoing
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Date: 03-24-2026|Location: N/A|Recall No: Z-1806-2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
RECALLClass IIOngoing
Potential for detachment of a distal tip component of the device during use.
Date: 03-23-2026|Location: N/A|Recall No: Z-1854-2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
RECALLClass IIOngoing
Potential for detachment of a distal tip component of the device during use.
Date: 03-23-2026|Location: N/A|Recall No: Z-1853-2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
RECALLClass IIOngoing
Potential for detachment of a distal tip component of the device during use.
Date: 03-23-2026|Location: N/A|Recall No: Z-1851-2026
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
RECALLClass IIOngoing
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Date: 03-23-2026|Location: N/A|Recall No: Z-1823-2026
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
RECALLClass IIOngoing
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Date: 03-20-2026|Location: N/A|Recall No: Z-1927-2026
Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.
RECALLClass IIOngoing
Increased rate of out-of-specification endotoxin results.
Date: 03-19-2026|Location: N/A|Recall No: Z-1820-2026
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
RECALLClass IIOngoing
Increased rate of out-of-specification endotoxin results.
Date: 03-19-2026|Location: N/A|Recall No: Z-1819-2026
Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.
RECALLClass IIOngoing
Increased rate of out-of-specification endotoxin results.
Date: 03-19-2026|Location: N/A|Recall No: Z-1818-2026
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
RECALLClass IIOngoing
Increased rate of out-of-specification endotoxin results.
Date: 03-19-2026|Location: N/A|Recall No: Z-1817-2026
Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.
RECALLClass IIOngoing
Increased rate of out-of-specification endotoxin results.
Date: 03-19-2026|Location: N/A|Recall No: Z-1816-2026
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.
RECALLClass IIOngoing
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
Date: 03-19-2026|Location: N/A|Recall No: Z-1805-2026
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1803-2026
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1802-2026
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1801-2026
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1800-2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1799-2026
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
RECALLClass IOngoing
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Date: 03-19-2026|Location: N/A|Recall No: Z-1798-2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
RECALLClass IIOngoing
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Date: 03-18-2026|Location: N/A|Recall No: Z-1941-2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
RECALLClass IIOngoing
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Date: 03-18-2026|Location: N/A|Recall No: Z-1940-2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
RECALLClass IIOngoing
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Date: 03-18-2026|Location: N/A|Recall No: Z-1939-2026
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
RECALLClass IIOngoing
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Date: 03-18-2026|Location: N/A|Recall No: Z-1938-2026
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
RECALLClass IIOngoing
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Date: 03-17-2026|Location: N/A|Recall No: Z-1633-2026
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
RECALLClass IIOngoing
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.
Date: 03-17-2026|Location: N/A|Recall No: Z-1632-2026
Flamingo Funnel Large, Model Number SQ20012-03
RECALLClass IIOngoing
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Date: 03-16-2026|Location: N/A|Recall No: Z-1926-2026
Flamingo Funnel Medium, Model Number SQ20012-02
RECALLClass IIOngoing
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Date: 03-16-2026|Location: N/A|Recall No: Z-1925-2026
Flamingo Funnel Small, Model Number SQ20012-01
RECALLClass IIOngoing
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Date: 03-16-2026|Location: N/A|Recall No: Z-1924-2026
Access Total T4 Calibrator, Catalog No. 33805
RECALLClass IIOngoing
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant patient being monitored for thyroid hormone supplementation, incorrect treatment or dose may be used. A delayed patient results could cause repeat blood draw with associated complications.
Date: 03-16-2026|Location: N/A|Recall No: Z-1922-2026
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
RECALLClass IIOngoing
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Date: 03-16-2026|Location: N/A|Recall No: Z-1824-2026
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
RECALLClass IIOngoing
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Date: 03-13-2026|Location: N/A|Recall No: Z-1895-2026
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
RECALLClass IIOngoing
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Date: 03-13-2026|Location: N/A|Recall No: Z-1894-2026
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
RECALLClass IIOngoing
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Date: 03-13-2026|Location: N/A|Recall No: Z-1893-2026
ARTIS Pheno VE30A and VE40A, Model 10849000
RECALLClass IIOngoing
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Date: 03-12-2026|Location: N/A|Recall No: Z-1814-2026
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
RECALLClass IIOngoing
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Date: 03-12-2026|Location: N/A|Recall No: Z-1810-2026