Skip to main content
15,654 recalls
High RiskFDA
Busse Hospital Disposables, Inc.
Core Biopsy Tray Catalog Number: 8673R4
Medical Devices·285 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 4.5MM DIAMOND TIP TROCAR WITH LARGE GLOVES Catalog Number:B1559
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Procedural Accessory Kit Catalog Number: 9665R2
Medical Devices·250 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Pump Refill Kit Catalog Number: 7347R1
Medical Devices·40 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Joint Injection Tray Catalog Number: 8561R1
Medical Devices·480 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Lumbar Tray Catalog 1091
Medical Devices·330 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Universal Nerve Block Tray Catalog Number: 9818
Medical Devices·60 affected·Feb 22, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests, material number 10381194, catalog n...
Medical Devices·10,755 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Nerve Block Tray Catalog Number: 3764R2
Medical Devices·250 affected·Feb 22, 2022
High RiskFDA
Conformis, Inc.
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Medical Devices·1 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Single Shot Epidural Tray Catalog Number: 6183R1
Medical Devices·425 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
Medical Devices·99 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
"3.2MM Pellet Insertion Tray with Medium Gloves" Catalog Number: B1351
Medical Devices·120 affected·Feb 22, 2022
High RiskFDA
Instrumentation Laboratory
ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R (Ref...
Medical Devices·2,725 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Medical Devices·120 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Sterile Epidural Tray Catalog Number: 6259R2
Medical Devices·50 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Port Tray Catalog 7607
Medical Devices·576 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
I.V. Start Kit Catalog 8172
Medical Devices·4,218 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354R1
Medical Devices·90 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Nerve Block Tray Catalog Number: 9342
Medical Devices·64 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Single Shot Epidural Tray Catalog Number: 6797R2
Medical Devices·40 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Universal Tray Catalog 1567
Medical Devices·96 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Nerve Block Tray Catalog Number: 6796R3
Medical Devices·200 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1362
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
Medical Devices·1,040 affected·Feb 22, 2022
High RiskFDA
Philips North America Llc
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of pati...
Medical Devices·77 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 4.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1365R1
Medical Devices·60 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R1
Medical Devices·300 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352
Medical Devices·30 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Cervical Tray Catalog 1089
Medical Devices·80 affected·Feb 22, 2022
High RiskFDA
Busse Hospital Disposables, Inc.
Stereo Breast Biopsy Tray Catalog Number: 2383R1
Medical Devices·23 affected·Feb 22, 2022
High RiskFDA
Sa3, Llc
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Medical Devices·156 affected·Feb 21, 2022
High RiskFDA
Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Medical Devices·13 affected·Feb 21, 2022
High RiskFDA
Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Medical Devices·8 affected·Feb 21, 2022
High RiskFDA
Ge Healthcare, Llc
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
Medical Devices·10 affected·Feb 18, 2022
High RiskFDA
Ge Healthcare, Llc
SIGNA Excite 3T. Magnetic Resonance Imaging System
Medical Devices·55 affected·Feb 18, 2022
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System
Medical Devices·76 affected·Feb 18, 2022
High RiskFDA
Dna Genotek Inc.
ORAcollect RNA: ORE-100
Medical Devices·17,080 affected·Feb 18, 2022
High RiskFDA
Ge Healthcare, Llc
1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
Medical Devices·653 affected·Feb 18, 2022
High RiskFDA
Dna Genotek Inc.
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100...
Medical Devices·2,375,514 affected·Feb 18, 2022
High RiskFDA
Deerfield Imaging, Inc.
Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #11...
Medical Devices·24 affected·Feb 17, 2022
High RiskFDA
Kaneka America Corp
LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model...
Medical Devices·138 affected·Feb 17, 2022
RecallFDA
Cytocell Ltd.
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Medical Devices·5 affected·Feb 14, 2022
High RiskFDA
Baxter Healthcare Corporation
Compella Therapy Air Supply Unit
Medical Devices·6,022 affected·Feb 14, 2022
RecallFDA
Cook Medical Incorporated
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP...
Medical Devices·24,641 affected·Feb 14, 2022
High RiskFDA
Biomet, Inc.
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, whic...
Medical Devices·12 affected·Feb 14, 2022