Browse Device Recalls
1,550 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,550 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 1,550 FDA device recalls in 2012.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 2, 2012 | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Si... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 2, 2012 | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices... | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO ste... | Class II | King Systems Corp. |
| Nov 1, 2012 | CADstream software. Product Usage: CADstream is an image processing syst... | An incorrect biopsy or missed target could result if the incorrect grid is selected within the ap... | Class II | Merge Healthcare, Inc. |
| Nov 1, 2012 | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I ... | APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect bar... | Class II | Abbott Point of Care Canada Limited |
| Nov 1, 2012 | OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS ST... | Biomet has initiated this action following an investigation which identified that the thin shaft ... | Class II | Biomet, Inc. |
| Nov 1, 2012 | Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. T... | On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the ... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 1, 2012 | Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Cl... | It has been determined that, in some cases, pulley drive components have broken parts or have be... | Class II | Beckman Coulter Inc. |
| Nov 1, 2012 | OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLES... | Biomet has initiated this action following an investigation which identified that the thin shaft ... | Class II | Biomet, Inc. |
| Nov 1, 2012 | Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Impla... | The items in this lot are missing the ion implantation feature. The surface of the head may be so... | Class II | Biomet, Inc. |
| Nov 1, 2012 | VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... | Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... | Class III | Ortho-Clinical Diagnostics |
| Oct 31, 2012 | Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: U... | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu... | Class II | Cooper Surgical, Inc. |
| Oct 31, 2012 | Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intende... | The firm voluntarily recalled Biothane Restraint Cuffs, Catalog No. 2900, that did not meet the r... | Class II | J T Posey Company |
| Oct 31, 2012 | Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationa... | Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail sy... | Class II | Hill-Rom, Inc. |
| Oct 31, 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... | This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... | Class II | B Braun Medical, Inc. |
| Oct 31, 2012 | Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 ... | Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circu... | Class II | Cooper Surgical, Inc. |
| Oct 30, 2012 | Philips Digital Diagnost Stationary radiographic system | When the operator for a wall stand view selects an "image rotation" different from default, or su... | Class II | Philips Healthcare Inc. |
| Oct 30, 2012 | Philips Digital Diagnost Software Version R2.0.2 Product Usage: This syst... | With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in ... | Class II | Philips Healthcare Inc. |
| Oct 30, 2012 | Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill B... | The firm was notified by a customer that there was a burr on the inside end of the drill bit resu... | Class II | Orthohelix Surgical Designs Inc |
| Oct 29, 2012 | Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Devi... | Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achiev... | Class II | Cordis Corporation |
| Oct 26, 2012 | Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S le... | During a recent review of documentation Anspach determined that the current directions for use fo... | Class II | The Anspach Effort, Inc. |
| Oct 26, 2012 | BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold... | Battery may over-heat during charging and smoke | Class II | iwalk inc |
| Oct 26, 2012 | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira Inc. |
| Oct 26, 2012 | Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An... | Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling ... | Class II | Beckman Coulter Inc. |
| Oct 26, 2012 | Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Conn... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira Inc. |
| Oct 26, 2012 | Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software... | The volume control knob on some Plum A+ single channel infusers (located on the back of the infus... | Class II | Hospira Inc. |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, Inc. |
| Oct 25, 2012 | BioPlant, a dental bone grafting material. BioPlant has been assigned the pr... | The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may ... | Class II | Kerr Corporation |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, Inc. |
| Oct 25, 2012 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... | Class III | Volk Optical Inc |
| Oct 25, 2012 | INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... | A manufacturing defect has been identified which could results in the small tube becoming dislodg... | Class II | Carl Zeiss Meditec, Inc. |
| Oct 25, 2012 | The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorpor... | Re-usable video laryngoscope blades of the GlideScope GVL3, GVL4, and GVL5 were recalled due to p... | Class I | Verathon, Inc. |
| Oct 25, 2012 | Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Br... | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... | Class II | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| Oct 25, 2012 | Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. | Two complaints have been filed where Hoffman LRF Wires have broken during load bearing applicatio... | Class II | Stryker Howmedica Osteonics Corp. |
| Oct 25, 2012 | Animas Vibe Insulin Infusion Pump and System. These products are indicated... | Animas determined that keypad wear over time was contributing to an increased complaint rate asso... | Class II | Animas Corporation |
| Oct 25, 2012 | Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers... | When the operator for a wall stand view selects an "image rotation" different from default, or su... | Class II | Philips Healthcare Inc. |
| Oct 25, 2012 | Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are... | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... | Class II | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| Oct 25, 2012 | Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is ... | Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar M... | Class II | Quasar Bio-Tech, Inc. dba Silver Bay LLC |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Par... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... | B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. Th... | Class II | B Braun Medical, Inc. |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part#... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, P... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
| Oct 24, 2012 | Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... | Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 24, 2012 | Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15... | The recall was initiated because Superstat Corporation has confirmed that no documentation are av... | Class II | Superstat Corp |
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.