Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Beekley Corporation
TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.
Medical Devices·3,384,024 affected·Jun 13, 2018
High RiskFDA
Bard Medical Division
Arctic Sun Temperature Management System, Model 5000. The Arctic Sun¿ 5000 model is a non-invasive, thermal regulating system, indica...
Medical Devices·5,608 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 7402...
Medical Devices·64,642 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 7402...
Medical Devices·42,050 affected·Jun 13, 2018
High RiskFDA
Smith & Nephew, Inc.
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 7402121...
Medical Devices·10,792 affected·Jun 13, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Steri...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Double Spike, Ref ASC1201, pac...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Single Spike, Ref ASU1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/cas...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, pac...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Steri...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Canadian Hospital Specialties
MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector...
Medical Devices·10 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, 5mm x 33cm Probe, Double Spike, Ref ASU1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Single Spike, Ref ASU1220, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Cardinal Health 200, Llc
Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box,...
Medical Devices·63,020 affected·Jun 11, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: pro...
Medical Devices·13,503 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 1070503120...
Medical Devices·756 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705...
Medical Devices·72 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product...
Medical Devices·107 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: ...
Medical Devices·21,971 affected·Jun 8, 2018
High RiskFDA
Bio-rad Laboratories, Inc
MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory...
Medical Devices·5,212 affected·Jun 8, 2018
High RiskFDA
Ethicon, Inc.
PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G...
Medical Devices·4,992 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Prod...
Medical Devices·305 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: pr...
Medical Devices·2,421 affected·Jun 8, 2018
High RiskFDA
Stryker Neurovascular
Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Prod...
Medical Devices·6,269 affected·Jun 8, 2018
High RiskFDA
Bio-rad Laboratories, Inc
MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests...
Medical Devices·3,632 affected·Jun 8, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCI...
Medical Devices·5,200 affected·Jun 7, 2018
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED ...
Medical Devices·5,200 affected·Jun 7, 2018
High RiskFDA
Neomed Inc
NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The pr...
Medical Devices·208,260 affected·Jun 4, 2018
RecallFDA
Richard-allan Scientific Company
EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use wi...
Medical Devices·1,039 affected·Jun 4, 2018
High RiskFDA
Fx Solutions
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the trea...
Medical Devices·131 affected·Jun 4, 2018
High RiskFDA
B. Braun Medical, Inc.
26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
Medical Devices·12,320 affected·Jun 4, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
Medical Devices·40 affected·May 30, 2018
High RiskFDA
Baxter Healthcare Corporation
FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter**...
Medical Devices·46,908 affected·May 30, 2018
High RiskFDA
Ge Healthcare Finland Oy
GE Healthcare CARESCAPE Monitor B650
Medical Devices·69,231 affected·May 25, 2018
High RiskFDA
Ge Healthcare, Llc
CT Goldseal Optima CT 600
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Revolution EVO 3.6, labeled as a. HVY WAUK; b. LONG HINO; c. LONG WAUK; d. MID BJG; e. MID WAUK.
Medical Devices·42 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive its...
Medical Devices·25 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery MI Digital Ready
Medical Devices·42 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sortin...
Medical Devices·495 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the...
Medical Devices·4 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Optima CT 520
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Optima CT 540
Medical Devices·42 affected·May 24, 2018
High RiskFDA
Ge Healthcare, Llc
Revolution CT 160 1.5D STD WAUK
Medical Devices·42 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intellige...
Medical Devices·283 affected·May 24, 2018
RecallFDA
Beckman Coulter Inc.
Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc...
Medical Devices·58 affected·May 24, 2018