Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 18, 2013 | ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... | HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass... | Class III | Horiba Instruments, Inc dba Horiba Medical |
| Dec 13, 2013 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10... | Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... | Class II | Highland Metals, Inc. |
| Dec 13, 2013 | SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10... | Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... | Class II | Highland Metals, Inc. |
| Dec 12, 2013 | Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warme... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is inten... | On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual... | Class II | King Systems Corp. |
| Dec 12, 2013 | Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthc... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled i... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 20... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 12, 2013 | Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M122... | Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mix... | Class II | GE Healthcare |
| Dec 11, 2013 | Latex Dental Dams labeled as Non-Latex Dental Dams | Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... | Class II | Coltene Whaledent Inc |
| Dec 10, 2013 | External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx... | The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fac... | Class II | BioHorizons Implant Systems Inc |
| Dec 10, 2013 | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 10, 2013 | CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 10, 2013 | Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 6, 2013 | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr... | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... | Class II | Bard Access Systems |
| Dec 6, 2013 | Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone... | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet... | Class II | Bard Access Systems |
| Dec 6, 2013 | Catheter, Continuous Flush The Merit Microcatheter is intended for general i... | Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a gr... | Class II | Merit Medical Systems, Inc. |
| Dec 4, 2013 | Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brillianc... | Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 3, 2013 | ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio... | Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri... | Class II | Baxter Corporation Englewood |
| Nov 26, 2013 | outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... | Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... | Class II | Biomet, Inc. |
| Nov 26, 2013 | G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 | Investigation identified that the outer label, inner label, and patient label all have the incorr... | Class II | Biomet, Inc. |
| Nov 26, 2013 | Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial... | Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Nov 25, 2013 | Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plasti... | Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of ste... | Class II | Navilyst Medical, Inc. |
| Nov 21, 2013 | Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg ... | Individual discs in the lot may not be sufficiently impregnated with antibiotic, resulting in sma... | Class II | Remel Inc |
| Nov 20, 2013 | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 20, 2013 | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,... | Lots were labeled with incorrect expiration dates on secondary package (carton). The primary pac... | Class II | CooperVision Inc. |
| Nov 20, 2013 | Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straig... | Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scis... | Class III | Edwards Lifesciences, LLC |
| Nov 18, 2013 | CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 18, 2013 | Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 18, 2013 | Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... | Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... | Class II | Medtronic Neurosurgery |
| Nov 14, 2013 | Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Th... | Modification of the bacterial overflow guard (filter) and related changes to product labeling. | Class II | Smith & Nephew Inc. |
| Nov 14, 2013 | Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wou... | Modification of the bacterial overflow guard (filter) and related changes to product labeling. | Class II | Smith & Nephew Inc. |
| Nov 6, 2013 | IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 ... | potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000... | Class II | Siemens Healthcare Diagnostics |
| Nov 6, 2013 | Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeo... | KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper w... | Class II | Karl Storz Endoscopy America Inc |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M003168191... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Prod... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM; Catalog Number: M0031441920... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340; Product is ... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product i... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M003168190... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM; Catalog Number: M0031441930... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030; Pro... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product i... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
| Nov 4, 2013 | Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is... | Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... | Class II | Stryker Neurovascular |
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.