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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 66 of 1581

Evidence Product Join Root cause
device-recall:cfres:196911 DeRoyal SPINAL FUSION PACK, REF 89-7515.13 Official recall number · Z-0597-2023 Nonconforming Material/Component
device-recall:cfres:196757 CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 Official recall number · Z-0954-2023 Process control
device-recall:cfres:196727 BD Pyxis MedBank System - Product Label/labeling pending Official recall number · Z-0928-2023 Software design
device-recall:cfres:197494 DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10 Official recall number · Z-0927-2023 Packaging change control
device-recall:cfres:197503 Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11CS; d. STERILE BLADE NO. 11 STAINLESS STEEL, Item Number: CISION11SS; e. STERILE BLADE NO. 11 CARBON STEEL RIB, Item Number: CISION11CSR; f. STERILE BLADE NO. 15 STAINLESS STEEL, Item Number: CISION15SS; g. STERILE BLADE NO. 15 CARBON STEEL, Item Number: CISION15CS; h. STERILE BLADE NO. 15 CARBON STEEL RIB, Item Number: CISION15CSR; i. STERILE BLADE NO. 20 STAINLESS STEEL, Item Number: CISION20SS; j. STERILE BLADE NO. 22 CARBON STEEL, Item Number: CISION22CS; k. STERILE BLADE NO. 22 STAINLESS STEEL, Item Number: CISION22SS. ***Expansion on 02/06/2023 with the following additional products: l. STERILE BLADE NO. 12 STAINLESS STEEL, Item Number: CISION12SS; m. STERILE BLADE NO. 20 CARBON STEEL, Item Number: CISION20CS; n. STERILE BLADE NO. 21 CARBON STEEL, Item Number: CISION21CS; o. STERILE BLADE NO. 21 STAINLESS STEEL, Item Number: CISION21SS. Indicated for use in surgical procedures where tissue separation is necessary. Official recall number · Z-0930-2023 Under Investigation by firm
device-recall:cfres:196324 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 7-1/2" (190MM), REF F-1113 Official recall number · Z-0383-2023 Under Investigation by firm
device-recall:cfres:196336 CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENGTH 4-3/4" (120MM), REF F-3015 Official recall number · Z-0395-2023 Under Investigation by firm
device-recall:cfres:196318 Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040 Official recall number · Z-0378-2023 Under Investigation by firm
device-recall:cfres:196325 Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED IRRIGATING OVERALL LENGTH 7-1/2" (190MM), REF F-1300 Official recall number · Z-0384-2023 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:196068 ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/4 in., 19-64mm, REF 416975. For the management of stoma output following a colostomy or ileostomy procedure. Official recall number · Z-0128-2023 Under Investigation by firm
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:196636 regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenience kit Official recall number · Z-0290-2023 Component change control
device-recall:cfres:196009 Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement therapies. Official recall number · Z-0082-2023 Error in labeling
device-recall:cfres:196092 N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299 Official recall number · Z-0094-2023 Under Investigation by firm
device-recall:cfres:196087 N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297 Official recall number · Z-0093-2023 Under Investigation by firm
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:196046 Medicina Oral Tip Syringe 0.5ml Code: OT005 Official recall number · Z-0109-2023 Nonconforming Material/Component
device-recall:cfres:196119 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings. Official recall number · Z-0097-2023 Under Investigation by firm
device-recall:cfres:196117 EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component. Official recall number · Z-0126-2023 Process control
device-recall:cfres:196101 ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. Official recall number · Z-0102-2023 Under Investigation by firm

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