Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 2, 2018 | AF 550 x 5ML/HR 2ML 60LO CPNB, Product code MT5060XL CPNB, Arrow AutoFuser Di... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF550x5ML/H 2ML 60LO 6" DUAL CATHS, 4.5", Product MT5060XLYK5 CP, Arrow AutoF... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB, Product code MVBX60XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB, Product code MVBT15XL-CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB, Product code MVBT30XL CPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The... | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Oct 2, 2018 | Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 Th... | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Oct 2, 2018 | AF 550 x 5ML/H 6" DUAL CATHS, 4.5", Product code MC0050XLYK5 CP, Arrow AutoFu... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF 550 x 5ML/H 6" CATH, 4.5" IN, Product code MC0050XLSK5 CP, Arrow AutoFuser... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Aff... | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Oct 2, 2018 | AF w/AS 550 x 1-14 ml/hr, 5ml30 LOCPNB, Product code MVBX30XLCPNB, Arrow Auto... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Dispo... | Possible cracks on the body of the fill port connector, which may result in a leak. If the leak i... | Class II | Arrow International Inc |
| Oct 2, 2018 | Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Aff... | The set screw is not able to advance or reverse from the original position in the nail. | Class II | Zimmer Biomet, Inc. |
| Oct 1, 2018 | MEVION S250i | Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped | Class II | Mevion Medical Systems, Inc. |
| Oct 1, 2018 | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile ... | Pouches from this lot are not sealed compromising the sterility | Class II | LeMaitre Vascular, Inc. |
| Oct 1, 2018 | YXLON Cheetah cabinet X-Ray System Product Usage: The products are genera... | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 102... | Class II | Comet Technologies Usa Inc |
| Oct 1, 2018 | YXLON Cougar Cabinet X-Ray System Product Usage: The products are general... | Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 102... | Class II | Comet Technologies Usa Inc |
| Oct 1, 2018 | C3 Wave App, v. 2.0.5 | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Up... | Class II | Medical Components, Inc dba MedComp |
| Oct 1, 2018 | PremierPro Aluminum Adjustable Walker | This recall is due to a mandated order from the FDA for stock recovery and return of the imported... | Class II | SVS LLC |
| Sep 28, 2018 | TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar... | The WHD/WHV impactors can rust over time due to an improper manufacturing process. | Class II | TriMed Inc. |
| Sep 28, 2018 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AI... | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AI... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, R... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The fi... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 28, 2018 | P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type:... | It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. ... | Class II | Paragon 28, Inc. |
| Sep 28, 2018 | Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material... | The terminals on the plug may become loose and overheat. | Class II | Siemens Medical Solutions USA, Inc. |
| Sep 28, 2018 | TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on t... | The spring on the PEG-Extender can rust due to the type of steel used to manufacture it. | Class II | TriMed Inc. |
| Sep 28, 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model... | Thermal chamber motors have electrical cables with single insulation rather than the required dou... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 28, 2018 | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name ... | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | Class II | TriMed Inc. |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | INFUSE Bone Graft X SMALL KIT REF 7510100 | The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sp... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93504, ELBOW STERILE KIT, UDI: (01)18054... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-36501, RADIOLUCENT WRIST FIXATOR KIT COM... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERI... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93502, LOWER LIMB DIAPHYSEAL STERILE KIT... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93502US, TIBIA FEMUR DIAPHYSEAL STERILE KI... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, R... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | Aisys CS2 Anesthesia System. Sold under the following product names: AISYS,... | Upgraded Aisys anesthesia devices and Aisys CS2 anesthesia devices with PSVPro Spontaneous Breath... | Class II | GE Healthcare, LLC |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93503US, ANKLE TRANSFIX PIN STERILE KIT,... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 ... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
| Sep 27, 2018 | ORTHOFIX Catalogue Number: ref: 99-93501JP, PELVIS STERILE KIT (STERILE GAMMA... | As a result of complaint investigations it was determined that batches of drill bits have a geome... | Class II | Orthofix Srl |
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.