Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Stradis Healthcare
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Medical Devices·300 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Medical Devices·2,779 affected·Dec 15, 2022
High RiskFDA
Medtronic Navigation, Inc.
AxiEM" Non-Invasive Patient Tracker
Medical Devices·1,867 affected·Dec 15, 2022
High RiskFDA
Biomet, Inc.
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femo...
Medical Devices·7 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0...
Medical Devices·21,755 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Medical Devices·2,500 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Medical Devices·1,175 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Henry Shein CYSTO SET UP PACK, 20 per case. Distributed by Henry Schein.
Medical Devices·1,040 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Medical Devices·180 affected·Dec 15, 2022
High RiskFDA
Stradis Healthcare
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Medical Devices·600 affected·Dec 15, 2022
High RiskFDA
W L Gore & Associates, Inc.
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Medical Devices·14 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
Medical Devices·0 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
Medical Devices·921 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
Medical Devices·1,920 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
Medical Devices·750 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2223
Medical Devices·2,259 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2227
Medical Devices·7,129 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2212
Medical Devices·892 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225
Medical Devices·4,112 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190
Medical Devices·3,507 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
Medical Devices·4,111 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214
Medical Devices·3,550 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
Medical Devices·1,150 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230
Medical Devices·29,515 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
Medical Devices·5,680 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228
Medical Devices·15,493 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213
Medical Devices·220 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211
Medical Devices·1,768 affected·Dec 14, 2022
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191
Medical Devices·3,520 affected·Dec 14, 2022
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
Medical Devices·224 affected·Dec 12, 2022
High RiskFDA
Steris Corporation
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring ...
Medical Devices·105 affected·Dec 12, 2022
High RiskFDA
Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and...
Medical Devices·857 affected·Dec 12, 2022
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 e...
Medical Devices·22,156 affected·Dec 12, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max
Medical Devices·886 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, ...
Medical Devices·45,285,351 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
Medical Devices·1,616,714 affected·Dec 9, 2022
CriticalFDA
Smiths Medical Asd Inc.
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24...
Medical Devices·47,595,495 affected·Dec 9, 2022
High RiskFDA
Teleflex Llc
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tub...
Medical Devices·39,690 affected·Dec 8, 2022
High RiskFDA
Detect Headquarters
Detect Covid-19 Test Product/Model Number: 21205
Medical Devices·10,142 affected·Dec 8, 2022
High RiskFDA
Teleflex Llc
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
Medical Devices·2,270 affected·Dec 8, 2022
High RiskFDA
The Anspach Effort, Inc.
Pediatric Craniotome Ref:CRANI-P-G1
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
FUSION Dual Pump Packs, REF: OPO73
Medical Devices·7,644 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and sh...
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Mobius Imaging, Llc
MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.
Medical Devices·303 affected·Dec 7, 2022
High RiskFDA
The Anspach Effort, Inc.
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping b...
Medical Devices·6,059 affected·Dec 7, 2022
High RiskFDA
Zimmer, Inc.
Identity Shoulder System Resection Planer 35mm Resection Planer
Medical Devices·84 affected·Dec 7, 2022
High RiskFDA
Zimmer, Inc.
NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
Medical Devices·1,049 affected·Dec 6, 2022