| device-recall:cfres:196587 |
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540 |
Official recall number · Z-0223-2023 |
Under Investigation by firm |
| device-recall:cfres:196289 |
CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST |
Official recall number · Z-0212-2023 |
Under Investigation by firm |
| device-recall:cfres:196484 |
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F.. |
Official recall number · Z-0228-2023 |
Process design |
| device-recall:cfres:196431 |
ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. UPN (1)ORISE ProKnife 1.5 mm Electrode - Kit M00519380; (2) ORISE ProKnife 2.0 mm Electrode - Kit M00519390; (3) ORISE ProKnife 3.0 mm Electrode - Kit M00519400 |
Official recall number · Z-0226-2023 |
Under Investigation by firm |
| device-recall:cfres:197080 |
BIOBALL P.AERUGINOSA NCTC 12924 550X20, CATALOG 56017 |
Official recall number · Z-0807-2023 |
Storage |
| device-recall:cfres:197133 |
ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927 |
Official recall number · Z-0849-2023 |
Storage |
| device-recall:cfres:197149 |
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01 |
Official recall number · Z-0865-2023 |
Storage |
| device-recall:cfres:197302 |
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium |
Official recall number · Z-0921-2023 |
Under Investigation by firm |
| device-recall:cfres:197159 |
PPM LOMBARD PRODUCTS IR&DB - TSA (32ML) 10PLT, CATALOG M1205-IR |
Official recall number · Z-0875-2023 |
Storage |
| device-recall:cfres:197060 |
VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341 |
Official recall number · Z-0787-2023 |
Storage |
| device-recall:cfres:197401 |
Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C |
Official recall number · Z-0913-2023 |
Under Investigation by firm |
| device-recall:cfres:197137 |
VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 |
Official recall number · Z-0853-2023 |
Storage |
| device-recall:cfres:197076 |
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851 |
Official recall number · Z-0803-2023 |
Storage |
| device-recall:cfres:197122 |
ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 |
Official recall number · Z-0841-2023 |
Storage |
| device-recall:cfres:197246 |
VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001 |
Official recall number · Z-0907-2023 |
Process design |
| device-recall:cfres:197366 |
Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 |
Official recall number · Z-0909-2023 |
Process control |
| device-recall:cfres:197117 |
VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 |
Official recall number · Z-0836-2023 |
Storage |
| device-recall:cfres:197384 |
DeRoyal Tonsillectomy Tray, REF 89-10698.01 |
Official recall number · Z-0906-2023 |
Nonconforming Material/Component |
| device-recall:cfres:197226 |
GEO-MED CATARACT PACK, REF 89-5790.08 |
Official recall number · Z-0709-2023 |
Nonconforming Material/Component |
| device-recall:cfres:196851 |
STRADIS HEALTHCARE, Endo Pack, Item No.682-509, |
Official recall number · Z-0550-2023 |
Packaging process control |
| device-recall:cfres:196960 |
DeRoyal TOTAL KNEE PACK, REF 89-9300.08 |
Official recall number · Z-0645-2023 |
Nonconforming Material/Component |
| device-recall:cfres:196793 |
Surgical room, SURGICAL PACK, Item No.40996WLS, oral surgery tray |
Official recall number · Z-0492-2023 |
Packaging process control |
| device-recall:cfres:196901 |
DeRoyal TRANS CANAL PACK, REF 89-7157.12 |
Official recall number · Z-0587-2023 |
Nonconforming Material/Component |
| device-recall:cfres:196984 |
DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02 |
Official recall number · Z-0669-2023 |
Nonconforming Material/Component |
| device-recall:cfres:196981 |
DeRoyal SHOULDER ARTHOSCOPY PACK, REF 89-9946.04 |
Official recall number · Z-0666-2023 |
Nonconforming Material/Component |