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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 12 of 1581

Evidence Product Join Root cause
device-recall:cfres:196668 regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit Official recall number · Z-0318-2023 Component change control
device-recall:cfres:196638 regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit Official recall number · Z-0292-2023 Component change control
device-recall:cfres:196726 Orthex Large Bone Shoulder Bolt, model no. AS-17 Official recall number · Z-0277-2023 Under Investigation by firm
device-recall:cfres:196573 PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% Sodium Chloride, and 5ml Ampule 1.5% Lidocaine HCl with Epinephrine 1:200,000. Official recall number · Z-0278-2023 Process control
device-recall:cfres:196636 regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit Official recall number · Z-0290-2023 Component change control
device-recall:cfres:196403 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape Official recall number · Z-0247-2023 Component change control
device-recall:cfres:196417 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape Official recall number · Z-0261-2023 Component change control
device-recall:cfres:196413 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape Official recall number · Z-0257-2023 Component change control
device-recall:cfres:196742 Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST Official recall number · Z-0333-2023 Process control
device-recall:cfres:196704 Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer Official recall number · Z-0352-2023 Process design
device-recall:cfres:196696 Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900) Official recall number · Z-0422-2023 Component design/selection
device-recall:cfres:197249 Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system Official recall number · Z-0476-2023 Process control
device-recall:cfres:196969 DeRoyal EMERGENT TRAUMA PACK, REF 89-9453.14 Official recall number · Z-0654-2023 Nonconforming Material/Component
device-recall:cfres:196944 DeRoyal KIT HEART B PACK, REF 89-9042.07 Official recall number · Z-0629-2023 Nonconforming Material/Component
device-recall:cfres:196923 DeRoyal HEART PACK, REF 89-8351.12 Official recall number · Z-0609-2023 Nonconforming Material/Component
device-recall:cfres:196854 STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142, Official recall number · Z-0553-2023 Packaging process control
device-recall:cfres:196929 DeRoyal SPINE PACK, REF 89-8361.10 Official recall number · Z-0615-2023 Nonconforming Material/Component
device-recall:cfres:196822 HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890 Official recall number · Z-0521-2023 Packaging process control
device-recall:cfres:196912 DeRoyal SPINAL FUSION PACK, REF 89-7515.14 Official recall number · Z-0598-2023 Nonconforming Material/Component
device-recall:cfres:197006 DeRoyal CARDIAC LINEN PACK, REF 89-10543.02 Official recall number · Z-0691-2023 Nonconforming Material/Component
device-recall:cfres:196843 STRADIS HEALTHCARE, Surgery PK, Item No.682-1728, Official recall number · Z-0542-2023 Packaging process control
device-recall:cfres:196874 DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15 Official recall number · Z-0561-2023 Nonconforming Material/Component
device-recall:cfres:196277 Cardinal Health Reusable Gel Pack, Hot/Cold Pack, 4.5 in. x 10 in., REF 70304A Official recall number · Z-0192-2023 Pending
device-recall:cfres:196626 X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673 Official recall number · Z-0222-2023 Process control
device-recall:cfres:196295 CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST Official recall number · Z-0217-2023 Under Investigation by firm

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