510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 62 of 1190
FDA device recalls, page 62 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0143-2026Class IICXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ)...Boston Scientific CorporationJCW
Z-0142-2026Class IICX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ)...Boston Scientific CorporationJCW
Z-0141-2026Class IILGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2)...Boston Scientific CorporationJCW
Z-0133-2026Class IIFERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND...Ferno-Washington IncFPO
Z-0140-2026Class IICX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2)...Boston Scientific CorporationJCW
Z-0139-2026Class IITENACIO Pump without InhibiZone; UPN: 72404420;Boston Scientific CorporationJCW
Z-0138-2026Class IITENACIO Pump with InhibiZone; UPN: 72404429;Boston Scientific CorporationJCW
Z-0132-2026Class IIThe failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a...Insulet CorporationQRX
Z-0035-2026Class IBD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing...CareFusion 303, IncFPA
Z-0045-2026Class IBronchovideoscope Olympus Bf Type 1T150OLYMPUS Corporation of the AmericasEOQ
Z-0137-2026Class IIMedline Adult Anesthesia Set, REF DYNJ39985GMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0113-2026Class ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F...Abbott MedicalOAE
Z-0112-2026Class ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF...Abbott MedicalOAE
Z-0111-2026Class ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF...Abbott MedicalOAE
Z-0110-2026Class ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF...Abbott MedicalOAE
Z-0109-2026Class ITactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D...Abbott MedicalOAE
Z-0153-2026Class IIBioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD...Biopro, Inc.JDI
Z-0152-2026Class IIBioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH...Biopro, Inc.LZY
Z-0151-2026Class IIBioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL...Biopro, Inc.LZO
Z-0150-2026Class IIBioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD...Biopro, Inc.KWY
Z-0149-2026Class IIBioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD...Biopro, Inc.LPH
Z-0148-2026Class IIBioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part...Biopro, Inc.LPH
Z-2619-2025Class IIJuggerknot Mini Soft Anchors, Model/Catalog Number: 912080Zimmer GmbHMBI
Z-2617-2025Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software...Draeger, Inc.BSZ
Z-2616-2025Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software...Draeger, Inc.BSZ
Z-0028-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-INoxbox LimitedMRN
Z-0029-2026Class INOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-INoxbox LimitedMRN
Z-2673-2025Class IIAshvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to...Medicalcommunications GmbHNFJ
Z-1794-2026Class IIMicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended...Siemens Healthcare Diagnostics Inc.LTT
Z-0365-2026Class IIICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3...Abbott MedicalONB
Z-0364-2026Class IIICU Medical ChemosafeLock Connecter REF: KL-FNU3Abbott MedicalONB
Z-0363-2026Class IIICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3Abbott MedicalONB
Z-0362-2026Class IIICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port...Abbott MedicalONB
Z-0361-2026Class IIICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector...Abbott MedicalONB
Z-0360-2026Class IIICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated...Abbott MedicalONB
Z-0359-2026Class IIICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip...Abbott MedicalONB
Z-0358-2026Class IIICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating...Abbott MedicalONB
Z-0357-2026Class IIICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35Abbott MedicalONB
Z-0356-2026Class IIICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34Abbott MedicalONB
Z-0355-2026Class IIICU Medical ChemoLock w/Mini Bag Spike REF: C-17Abbott MedicalONB
Z-0354-2026Class IIICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units REF: 011-CL-70S-20Abbott MedicalONB
Z-0353-2026Class IIICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955Abbott MedicalONB
Z-0352-2026Class IIICU Medical Graduated Connector w/ChemoLock Port REF: CL3900Abbott MedicalONB
Z-0351-2026Class IIICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360Abbott MedicalONB
Z-0350-2026Class IIICU Medical ChemoLock Port REF: CL2100Abbott MedicalONB
Z-0349-2026Class IIICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82Abbott MedicalONB
Z-0348-2026Class IIICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5Abbott MedicalONB
Z-0347-2026Class IIICU Medical ChemoLock Vial Spike, 20mm REF: CL-80SAbbott MedicalONB
Z-0346-2026Class IIICU Medical ChemoLock Closed Vial Spike REF: CL-80Abbott MedicalONB
Z-0345-2026Class IIICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72Abbott MedicalONB