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 |
|---|---|---|---|---|
| Jul 11, 2012 | Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporatio... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642... | Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could ... | Class II | Philips Healthcare Inc. |
| Jul 11, 2012 | Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufa... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model ... | In certain situations, loss of post exercise images can occur in Stress Echo. | Class II | Siemens Medical Solutions USA, Inc. |
| Jul 11, 2012 | AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ven... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 ... | When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always st... | Class II | Philips Healthcare Inc. |
| Jul 11, 2012 | Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation,... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable ... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The ... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufact... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufact... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 11, 2012 | Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-0... | A fault in a high voltage relay in the 0-arm¿ Imaging System might cause the relay to overheat an... | Class II | Medtronic Navigation, Inc. |
| Jul 11, 2012 | Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufacture... | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | Class I | Ventlab Corporation |
| Jul 10, 2012 | Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 344... | Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... | Class II | Winco Mfg., LLC |
| Jul 10, 2012 | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual... | Defective camera: There is a possibility that the connection of the wires to the connector may be... | Class III | Berchtold Corp. |
| Jul 10, 2012 | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting componen... | When users selected "Left stenosis" in the "Graft Duplex Conclusion" section in IMPAX CV Reportin... | Class II | AGFA Corp. |
| Jul 10, 2012 | Optima XR200amx. Mobile general purpose radiographic imaging of the human he... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| Jul 10, 2012 | Optima XR220amx Mobile general purpose radiographic imaging of the human h... | Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects... | Class II | GE Healthcare, LLC |
| Jul 10, 2012 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***... | Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The rec... | Class II | Winco Mfg., LLC |
| Jul 9, 2012 | Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mam... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 9, 2012 | Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and p... | On 07/09/2012, Apheresis Technologies, Inc. initiated a recall on the Plasma Pump Model PP-04a du... | Class II | Apheresis Technologies, Inc. |
| Jul 9, 2012 | Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mam... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 9, 2012 | Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mam... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 9, 2012 | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics pa... | The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control,... | Class III | Iris Diagnostics |
| Jul 9, 2012 | SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is u... | SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parame... | Class II | Sentec AG |
| Jul 9, 2012 | Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: desig... | Digital Skin Mammography Marker separating from the backing of the spot material | Class II | Beekley Corporation |
| Jul 6, 2012 | Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic ... | Baxter discovered that a Baxter technical service representative was providing incorrect instruct... | Class II | Baxter Healthcare Renal Div |
| Jul 6, 2012 | Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, Un... | The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pu... | Class II | Beckman Coulter Inc. |
| Jul 6, 2012 | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConM... | ConMed Linvatec recalled one lot of their PopLok bone Punch 3.5MM because the metal shaft diamete... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Jul 6, 2012 | Finapres Medical Systems Portapres with NiMh battery pack Product Usage:... | Battery may become hot and leak | Class II | FMS, Finapres Medical Systems BV |
| Jul 5, 2012 | Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... | Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable... | Class II | Stryker Spine |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are inte... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a ste... | Package seam of some units may not remain properly sealed to ensure the contents might not be ste... | Class II | Kimberly-Clark Corporation |
| Jul 5, 2012 | The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyze... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for... | A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... | Class II | Radiometer America Inc |
| Jul 5, 2012 | MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product... | Package seam of some units may not remain properly sealed to ensure the contents might not be ste... | Class II | Kimberly-Clark Corporation |
| Jul 5, 2012 | Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S... | There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical caut... | Class I | Synthes USA HQ, Inc. |
| Jul 3, 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID s... | Distal part of the anchor may break on insertion into bone during surgery | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 3, 2012 | Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 932... | STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specificat... | Class II | Steris Corporation |
| Jul 3, 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures (COBRAID-bl... | Distal part of the anchor may break on insertion into bone during surgery | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 3, 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBR... | Distal part of the anchor may break on insertion into bone during surgery | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 3, 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, C... | Distal part of the anchor may break on insertion into bone during surgery | Class II | Smith & Nephew, Inc. Endoscopy Division |
| Jul 3, 2012 | Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seiza... | Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load ... | Class II | Stryker Howmedica Osteonics Corp. |
| Jul 3, 2012 | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral so... | The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR... | Class II | Chicago X-Ray Systems, Inc. |
| Jul 3, 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables u... | The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when use... | Class II | OPTI Medical Systems, Inc |
| Jul 2, 2012 | Varian brand Varian ARIA Oncology Information System, Import Export applicat... | A software anomaly has been identified with the Import Export Application version 11.0 where MLC... | Class II | Varian Medical Systems, Inc. Oncology Systems |
| Jul 2, 2012 | SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Ins... | Some clip applier units may be inadequate to achieve clip closure. | Class II | Transenterix, Inc |
| Jul 2, 2012 | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman,... | Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA... | Class II | Mc-NEIL-PPC, Inc. |
| Jul 2, 2012 | Drager PT 4000 Phototherapy System | A routine internal quality check found that the Drager PT 4000 Phototherapy System is fitted with... | Class II | Draeger Medical Systems, 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.