Medical Device Recalls
FDA recalls of medical devices including implants, diagnostic equipment, and surgical tools.
13,600 total recalls
SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474
Cardinal Health
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Elekta, Inc.
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Securitas Healthcare LLC
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001699;
Beaver Visitec International, Inc.
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
TELEFLEX LLC
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Conformis, Inc.
Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505
MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Kit SKU DYNJ16826O
Medline Industries, LP
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) ST
MEDLINE INDUSTRIES, LP - Northfield
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Stryker Sustainability Solutions
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with th
Dynex Technologies, Inc.
VITROS Immunodiagnostic Products Troponin I ES Calibrators
ORTHO-CLINICAL DIAGNOSTICS
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00
Instrumentation Laboratory
KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from AT
Microbiologics Inc
FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822
Ferno-Washington Inc
P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
Fort Defiance Industries, LLC
DeRoyal SHOULDER PACK, REF 89-6830.13
DeRoyal Industries Inc
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component
Abbott Diabetes Care, Inc.
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
CAREFUSION
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringe
Medline Industries, LP
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavi
Atrium Medical Corporation
Dr¿ger Perseus A500 Anesthesia Workstation
Draeger Medical, Inc.
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
MEDLINE INDUSTRIES, LP - Northfield
American Contract Systems Gyn Laparoscopy convenience kit
American Contract Systems, Inc.
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 301
Smiths Medical ASD Inc.
CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 8-1/2" (215MM), REF F-5002
Carefusion 2200 Inc
MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B
MEDLINE INDUSTRIES, LP - Northfield
Gut Microbiome Test Medium
GET TESTED INTERNATIONAL AB
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infus
B Braun Medical Inc
Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW CONT Model/Catalog Number: 91846 Product Description: NON-Steri
Jiangsu Shenli Medical Production Co., Ltd.
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