Browse Device Recalls
261 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 261 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 261 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 28, 2012 | ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is inten... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This devi... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Cu... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only***... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployme... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Th... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia At... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sle... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only***... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This devi... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty A... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This dev... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device ... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| Nov 28, 2012 | ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This devic... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. Th... | Class II | The Anspach Effort, Inc. |
| 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. |
| Sep 5, 2012 | Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guar... | Contact between the bur and bur guard could generate metal fragments that may or may not be visi... | Class II | The Anspach Effort, Inc. |
| Jun 11, 2012 | Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutt... | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... | Class II | The Anspach Effort, Inc. |
| Jun 11, 2012 | Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome.... | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a ca... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping del... | Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details ... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. In... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are includ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. In... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Jan 9, 2012 | "***Electric Systems Foot Control with Direction Only***Rx Only***" Produc... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... | Class II | The Anspach Effort, Inc. |
| Jan 9, 2012 | "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***"... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... | Class II | The Anspach Effort, Inc. |
| Jan 9, 2012 | "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting a... | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due t... | Class II | The Anspach Effort, 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.