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Browse Device Recalls

262 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 262 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 262 FDA device recalls.

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DateProductReasonClassFirm
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 21, 2019 Torcon NB Advantage Catheters - Product Usage: Intended for use in the periph... The potential compromise of the sterility of products from an undersealed chevron in the packagin... Class II Cook Inc.
Oct 3, 2019 Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos ... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Oct 3, 2019 Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embr... Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter ... Class II Cook Inc.
Sep 17, 2019 Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Pr... Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip ... Class II Cook 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 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 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.
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 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.
Jan 4, 2019 Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108 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 C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 ... 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 Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 ... 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 Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598 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 Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 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 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629... 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 Urethral Dilator Set, Global Product No. G14185 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 Wire Guide, Guidewire, Global Product Number G14326 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 Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G1... 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 Double Pigtail Ureteral Stent Set, Global Product No. G15076 G1490... 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 Entry Set, Nephrostomy Catheter, Global Product No. G14649 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 Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844 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 Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 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 Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Cathe... 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.