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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
Jun 7, 2019 PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... Class III Polymer Technology Systems, Inc.
Jun 4, 2019 Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Ite... The products do not have sufficient data to support the labeled shelf life of 10 years. Class II Zimmer Biomet, Inc.
Jun 4, 2019 Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usa... The products do not have sufficient data to support the labeled shelf life of 10 years. Class II Zimmer Biomet, Inc.
Jun 3, 2019 The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies... Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and qua... Class II Roche Diagnostics Corporation
May 28, 2019 K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Expre... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: The... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 28, 2019 DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: Th... There is a potential for weak seals of the sterile packaging. Class II Zimmer Biomet, Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Cat... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 24, 2019 Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Ca... Multiple complaints were received for balloons bursting below the rated burst pressure. Potentia... Class I Cook Inc.
May 3, 2019 Accu-Chek Connect Diabetes Management App Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to t... Class II Roche Diabetes Care, Inc.
May 2, 2019 Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT The products may have been manufactured without the bottom seal on the outer packaging, compromis... Class II Cook Inc.
Apr 26, 2019 Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-10... may contain a damaged gray safety lock knob, which could potentially result in difficulty or an i... Class II Cook Inc.
Apr 22, 2019 Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: ... Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... Class II Cook Inc.
Apr 22, 2019 Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.... Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instru... Class II Cook Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 18, 2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item... Incorrect raw material used by the supplier in the manufacturing of the screw component, which co... Class II Zimmer Biomet, Inc.
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 9, 2019 Thoracentesis Set, RPN C-THS-850, Order # G03286 Affected products may have been manufactured with the catheter distal end hole too small Class II Cook Inc.
Apr 4, 2019 cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 4, 2019 cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic s... There is a potential for the tray input flap on the post analytical units to become loose, potent... Class III Roche Diagnostics Corporation
Apr 1, 2019 Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Head... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 28, 2019 T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet... There is a potential of fracture, bending or shearing of the driver. Class II Zimmer Biomet, Inc.
Mar 18, 2019 Albumin BCP Product Usage: ALBP is an in vitro test used for the quantit... The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due ... Class II Roche Diagnostics Corporation
Mar 15, 2019 cobas e 801 immunoassay analyzer The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCel... Class II Roche Diagnostics Corporation
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Mar 1, 2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Tita... Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for th... Class II Zimmer Biomet, Inc.
Feb 28, 2019 Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory inst... Lack of an adequate sterilization validation Class II Zimmer Biomet, Inc.
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 25, 2019 Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro... Updates to the Instructions for Use. Class III Cook Medical Incorporated
Feb 4, 2019 Cobas¿ infinity central lab IT solution Material Number: 07154003001 Ca... Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential ... Class II Roche Diagnostics Corporation
Feb 1, 2019 Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. ... The products were manufactured without a back bevel on the needle tip. This could cause damage to... Class I Cook Inc.
Jan 16, 2019 Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 16, 2019 CHOL+HDL+GLU test strips, REF 2412 Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... Class II Polymer Technology Systems, Inc.
Jan 4, 2019 Fixed Core Straight Safety Wire Guide, Guidewire, Global Product Number G14285 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 ... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G499... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G1... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.