Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2024-12-18FDA-DeviceMicro-X Ltd.Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
- 2024-12-18FDA-DeviceMicro-X Ltd.Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
- 2024-12-18FDA-DeviceMicroline Surgical, Inc.Class IIMicroscissor Tip (Disposable); Microline Catalog #: 3122.
A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.
- 2024-12-18FDA-DeviceICU Medical, Inc.Class IIChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
Due to finished goods incorrectly packaged and labeled.
- 2024-12-18FDA-DeviceFolsom Metal Products, Inc.Class IISmall DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
Units were not intended for commercial distribution and inadvertently distributed.
- 2024-12-18FDA-DeviceFolsom Metal Products, Inc.Class IIDKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
Units were not intended for commercial distribution and inadvertently distributed.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 3) BASIC BACK CDS, REF CDS780147N; 4) INSTRUMENTED BACK CDS, REF CDS780148Q; 5) INSTRUMENTED BACK CDS, REF CDS780148R; 6) TOTAL HIP, REF CDS920027W; 7) TOTAL HIP, REF CDS920027X; 8) TOTAL HIP, REF CDS920027Y; 9) TOTAL KNEE CDS-LF, REF CDS940047AF; 10) TOTAL KNEE CDS-LF, REF CDS940047AG; 11) TOTAL HIP CDS-LF, REF CDS940048AF; 12) TOTAL HIP CDS-LF, REF CDS94004
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BREAST PACK, REF DYNJ65808C; 8) OCULOPLASTY PACK, REF DYNJ81798A; 9) OPHTHO PLASTIC, REF DYNJ902256C; 10) OCULAR, REF DYNJ909065; 11) OCULAR, REF DYNJ909065A; 12) PLASTIC EYE, REF DYNJVB91043A
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2) TOT/ GYN LITHOTOMY CDS, REF CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, REF CDS985431L; 4) GENERAL LITHOTOMY PACK, REF DYNJ44153G; 5) CHRISTUS AH GYN LAPAROSCOPY, REF DYNJ60924C; 6) D&C PACK, REF DYNJVB1280C; 7) D&C PACK, REF DYNJVB1280D
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF,
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, R
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R; 2) PELVISCOPY PACK-LF, REF DYNJ0843760I; 3) PELVISCOPY PACK-LF, REF DYNJ0843760J
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG CDS, REF CDS984995M; 3) MAJOR VAGINAL PACK-LF, REF DYNJ0826768P; 4) VAGINAL PACK, REF DYNJ59081C; 5)VAGINOPLASTY PACK, REF DYNJ65807C; 6) ACH MAJOR VAGINAL PACK, REF DYNJ67757B
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF, REF DYNJ0038440C; 8) NEURO PACK-LF, REF DYNJ0406347M; 9) NEURO-LF, REF DYNJ0484186M; 10) NEURO-LF, REF DYNJ0484186N; 11) NEURO VP SHUNT PACK-LF, REF DYNJ0843121K; 12) NEURO VP SHUNT/VAGAL NERVE-RF, REF DYNJ21925
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, REF CDS983465N; 3) BURN PACK, REF DYNJ63331D
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIRefer to RES or lead review memo for complete list of affected reference/catalog numbers
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, REF DYNJ0867331G; 6) TOTAL KNEE BASIN B PACK-LF, REF DYNJ0867555L; 7) ST. ANNE'S MINOR BASIN PACK, REF DYNJ24622K; 8) ST. ANNE'S MAJOR BASIN SET UP, REF DYNJ24628M; 9) MAJOR BASIN SET, REF DYNJ41285B; 10) BASIN P
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2) MAMMOPLASTY-LF, REF CDS983478M; 3) PLASTICS FREE FLAP, REF CDS983493M; 4) PLASTIC TORSO-LF, REF CDS983496L; 5) PLASTIC TORSO-LF, REF CDS983496M; 6) PLASTIC HEAD AND NECK-LF, REF CDS983498N; 7) ACH PLASTICS BREAST-LF, REF CDS983639J; 8) ACH PLASTICS BREAST-LF, REF CDS983639K; 9) BREAST ABD, REF CDS984267J; 10) DAY SURG PLASTIC CDS, REF CDS984993N; 11) DAY SURG PLASTIC CDS, REF CDS984993O; 12) DAY SURG PLASTIC
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF CDS860016R; 8) LAPAROTOMY CDS #31-RF, REF CDS860062R; 9) LAPAROTOMY CDS #31-RF, REF CDS860062S; 10) LAPAROSCOPY CDS, REF CDS860194I; 11) BASIC LAPAROSCOPY CDS, REF CDS920080R; 12) BASIC LAPAROSCOPY CDS, REF CDS92008
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A, REF CDS984895J; 9) T&A, REF CDS984895K; 10) HEAD NECK PACK-LF, REF DYNJ0101206D; 11) HEAD NECK PACK-LF, REF DYNJ0101206F; 12) MAJOR EAR PACK-LF, REF DYNJ0101314D; 13) NILES T A PACK, REF DYNJ0101397M; 14) NILES T
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, REF DYNJ81776A; 7) TAMPONADE, REF DYNJ82691
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
- 2024-12-11FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
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