Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3 Level, 45mm Material Number: 66-345 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 22mm Material Number: 66-122 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 88mm Material Number: 66-488 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 64mm Material Number: 66-464 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
CriticalFDA
Hamilton Co
HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19...
Medical Devices·4,729 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervic...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 95mm Material Number: 66-595 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 68mm Material Number: 66-468 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 80mm Material Number: 66-480 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 57mm Material Number: 66-357 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 60mm Material Number: 66-460 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 30mm Material Number: 66-230 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Qiagen Sciences Llc
SARS-CoV-2 Antigen Test
Medical Devices·1,092 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 10mm Material Number: 66-110 - Product Usage: intended for anterior cervical...
Medical Devices·65 affected·Jan 15, 2021
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 28mm Material Number: 66-228 - Product Usage: intended for anterior cervical ...
Medical Devices·0 affected·Jan 15, 2021
High RiskFDA
Covidien Llc
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of inguinal hernias v...
Medical Devices·129 affected·Jan 13, 2021
High RiskFDA
Bemer Int. Ag
Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC)...
Medical Devices·197,724 affected·Jan 13, 2021
High RiskFDA
Shent Usa, Inc.
Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devic...
Medical Devices·85 affected·Jan 12, 2021
High RiskFDA
Shent Usa, Inc.
Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through ...
Medical Devices·47 affected·Jan 12, 2021
High RiskFDA
Natus Manufacturing Limited
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cere...
Medical Devices·7 affected·Jan 12, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27...
Medical Devices·22,528 affected·Jan 11, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L INTL ONLY ULTRA S...
Medical Devices·20,817 affected·Jan 11, 2021
High RiskFDA
Ecolab Inc
Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during v...
Medical Devices·132 affected·Jan 11, 2021
High RiskFDA
Medtronic Neurosurgery
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL ...
Medical Devices·2,911 affected·Jan 11, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Medical Devices·60 affected·Jan 8, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ba...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal ...
Medical Devices·29,810,665 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Baxter Healthcare Corporation
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numb...
Medical Devices·2,314 affected·Jan 7, 2021
High RiskFDA
Cardinal Health 200, Llc
ChemoPlus" Chemo Prep & Admin Kit, CT4025
Medical Devices·137,346 affected·Jan 7, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX 25G 2.5MM, model no. NM-400U-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatme...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal in...
Medical Devices·7,400,000 affected·Jan 4, 2021
High RiskFDA
Aomori Olympus Co., Ltd.
INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM, model no. NM-400L-0623 - Product Usage: Used with endoscopes to perform endoscopic injection for th...
Medical Devices·7,400,000 affected·Jan 4, 2021