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 |
|---|---|---|---|---|
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm. Milex Part Number: ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex P... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary 1 5/8"", 41mm. Milex Part Number: MXKPEC04 ... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm. Milex Part Numbe... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm. Milex Part Number... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Proc... | LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidoc... | Class II | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Nu... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 26, 2013 | Cooper Surgical Gellhorn Flexible Pessary 3", 76mm. Milex Part Number: MXPGE... | Pessary mislabeled outer package may not reflect the size of the product contained in the package | Class III | Cooper Surgical, Inc. |
| Feb 25, 2013 | MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Prod... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: ... | When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control so... | Class II | Lifescan Inc |
| Feb 25, 2013 | CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. ... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for ... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 021689... | When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control so... | Class II | Lifescan Inc |
| Feb 25, 2013 | MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5... | Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets inclu... | Class II | Baxter Healthcare Corp. |
| Feb 25, 2013 | GOPump Elastometric infusion PumpKit with/ and without accesssories all conta... | Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became... | Class I | Symbios Medical Products, LLC |
| Feb 20, 2013 | 60 mm Rod, Item #BG1660 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 50 mm Screw, Item #BG7050 Product Usage: Spinal Solutions distributes a v... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm C... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distrib... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | Set Screw, Item #BG3010 Product Usage: Spinal Solutions distributes a var... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 20, 2013 | 45 mm Screw, Item #BG7045 Product Usage: Spinal Solutions distributes a v... | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated b... | Class II | Spinal Solutions, LLC |
| Feb 19, 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003... | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with t... | Class III | Remel Inc |
| Feb 18, 2013 | Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solut... | It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging... | Class II | Ge Medical Systems Information T |
| Feb 14, 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 m... | The BD Vacutainer Urinalysis Transfer Straw Kit #364991, Lot 1335484 has preprinted polybags whic... | Class III | Becton Dickinson & Company |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 12, 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. ... | The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... | Class II | Polymedco, Inc |
| Feb 8, 2013 | BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, R... | Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay ... | Class II | Becton Dickinson & Co. |
| Feb 8, 2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Ave... | Orthodontic brackets distributed was incorrectly labeled. | Class III | Ultradent Products, Inc. |
| Feb 7, 2013 | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAP... | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... | Class II | Smith & Nephew Inc |
| Feb 7, 2013 | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAP... | 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm scre... | Class II | Smith & Nephew Inc |
| Feb 7, 2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medi... | Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Class II | Myco Medical Supplies Inc |
| Feb 4, 2013 | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessori... | EsophyX2Plus device was not validated under actual or simulated use conditions prior to distribut... | Class II | Endogastric Solutions Inc |
| Jan 28, 2013 | Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATES... | Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a ... | Class II | Diagnostica Stago, Inc. |
| Jan 25, 2013 | Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066... | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jan 25, 2013 | Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operato... | Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor),... | Class II | Nellcor Puritan Bennett Inc. (dba Covidien LP) |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 23, 2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 23, 2013 | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Pro... | Affected products have a labeled expiration date of one year too long. | Class III | Bion Enterprises Ltd |
| Jan 21, 2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needl... | The label on the device states that the item number is CLGY-2210 when the item number on the devi... | Class II | Churchill Medical Systems, Inc. |
| Jan 17, 2013 | SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... | Class II | Ormco/Sybronendo |
| Jan 17, 2013 | SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... | Class II | Ormco/Sybronendo |
| Jan 17, 2013 | KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Mod... | Missing symbols and manufacturing information on the clear carton label. The expiration dating s... | Class III | Carestream Health, Inc. |
| Jan 14, 2013 | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate... | Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labe... | Class II | Atricure Inc |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... | Class II | Acclarent, Inc. |
| Jan 11, 2013 | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. ... | Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additiona... | Class II | Acclarent, 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.